Ankle Inversion Sprain, Chronic Instability of Joint
Conditions
Keywords
Ankle Instability, Manual Therapy, Massage, Ankle Joint Mobilization, Biomechanics, Neuromuscular
Brief summary
ABSTRACT: Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a multifaceted condition linked with life-long residual symptoms and post-traumatic ankle osteoarthritis. Our long term goal is to develop intervention strategies to decrease disability associated with acute and chronic ankle injury and prevent posttraumatic ankle osteoarthritis. Conventional rehabilitation strategies, are only moderately successful because they ignore the full spectrum of residual symptoms associated with CAI. Manual therapies such as ankle joint mobilizations and plantar massage target sensory pathways not addressed by conventional treatments and have been shown to improve patient-reported outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these early results are promising, the underlying neuromuscular mechanisms of these manual therapies remain unknown. Therefore the objective of this R21 proposal is to determine the neuromuscular mechanisms underlying the improvements observed following independent ankle joint mobilization and plantar massage interventions in CAI patients. To comprehensively evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical excitability, and cortical mapping, sensory organization) will be assessed. Participants will then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over 2-weeks. Post-intervention assessments will be completed within 48-hours of the final treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral, spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also be assessed. The results of this investigation will elucidate multifaceted mechanisms of novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those with CAI.
Interventions
OTHERJoint Mobilization
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade II anterior to posterior ankle joint mobilizations with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
OTHERMassage
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Individuals with Chronic Ankle Instability which will be defined as those individuals who: * have sustained at least two lateral ankle sprains; * have experienced at least one episode of giving way within the past 6-months; * answer 4 or more questions of yes on the Ankle Instability Instrument; * have self-assessed disability scores of ≤90% on the Foot and Ankle Ability Measure; * have self-assessed disability scores ≤80% on the Foot and Ankle Ability Measure-Sport.
Exclusion criteria
for Chronic Ankle Instability will include: * known vestibular and vision problems, * acute lower extremities and head injuries (\<6 weeks), * chronic musculoskeletal conditions known to affect balance (e.g., Anterior Cruciate Ligament deficiency) and * a history of ankle surgeries to fix internal derangement. Participants will also be excluded if they have any of the following which are contraindications to Transcranial Magnetic Stimulation testing: * metal anywhere in the head (except in the mouth), * pacemakers, * implantable medical pumps, * ventriculo-peritoneal shunts, * intracardiac lines, * history of seizures, * history of stroke * history of serious head trauma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ML COP Velocity From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | % Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment. |
| 95% Confidence Ellipse From Baseline to Follow-Up | Baseline and 4-week Follow-Up | % Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment. |
| 95% Confidence Ellipse From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | % Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment. |
| AP TTB From Baseline to Follow-Up | Baseline and 4-week Follow-Up | % Modulation of AP Time-to-Boundary. First, time-to-Boundary is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed. |
| AP TTB From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | % Modulation of AP Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed. |
| ML TTB From Baseline to Follow-Up | Baseline and 4-week Follow-Up | % Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed. |
| ML TTB From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | % Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed. |
| AP COP Velocity From Baseline to Follow-up | Baseline and 4-week Follow-Up | % Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the follow-up assessment. |
| AP COP Velocity From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | % Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment. |
| ML COP Velocity From Baseline to Follow-Up | Baseline and 4-week Follow-Up | % Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the Follow-Up assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corticomotor Map Volume From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment. |
| Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Baseline and 4-week Follow-Up | A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment. |
| Cortical Silent Period From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the immediate post-treatment assessment. |
| Cortical Silent Period From Baseline to Follow-Up | Baseline and 4-week Follow-Up | A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the follow-up assessment. |
| Corticomotor Map Area From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the immediate post-treatment assessment. |
| Corticomotor Map Area From Baseline to Follow-Up | Baseline and 4-week Follow-Up | A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the follow-up assessment. |
| Corticomotor Map Volume From Baseline to Follow-Up | Baseline and 4-week Follow-Up | measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment. |
| Alpha Power Spectral Density From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate post-treatment assessment. |
| Alpha Power Spectral Density From Baseline to Follow-Up | Baseline and 4-week Follow-Up | A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate follow-up assessment. |
| Beta Power Spectral Density From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the immediate post-treatment assessment. |
| Beta Power Spectral Density From Baseline to Follow-Up | Baseline and 4-week Follow-Up | A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the follow-up assessment. |
| Gamma Power Spectral Density From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the immediate post-treatment assessment. |
| Gamma Power Spectral Density From Baseline to Follow-Up | Baseline and 4-week Follow-Up | A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the follow-up assessment. |
| Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the immediate post-treatment assessment. |
| Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Baseline and 4-week Follow-Up | Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the follow-up assessment. |
| 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. his analysis focused on baseline to the immediate post-treatment assessment. |
| 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline and 4-week Follow-Up | Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment. |
| 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the immediate post-treatment assessment. |
| 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline and 4-week Follow Up | Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment. |
| Soleus H:M Ratio From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses. |
| Soleus H:M Ratio From Baseline to Follow-Up | Baseline and 4-week Follow-Up | This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses. |
| Fibularis Longus H:M Ratio From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses. |
| Fibularis Longus H:M Ratio From Baseline to Follow-Up | Baseline and 4-week Follow-Up | This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses. |
| Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Baseline and 24-72 hours post intervention | A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Landing Loading Rate at 4-weeks Post Intervention | 4-weeks post intervention | Rate of weight acceptance while landing from a jump |
| Landing Ankle Dorsiflexion at Baseline | Baseline | Dorsiflexion angle of the ankle at initial contact while landing from a jump |
| Walking Loading Rate at 4-weeks Post Intervention | 4-weeks post intervention | Rate of weight acceptance while walking |
| Landing Loading Rate Immediately Post Intervention | 24-72 hours post intervention | Rate of weight acceptance while landing from a jump |
| Landing Loading Rate at Baseline | Baseline | Rate of weight acceptance while landing from a jump |
| Landing Ankle Dorsiflexion at 4-weeks Post Intervention | 4-weeks post intervention | Dorsiflexion angle of the ankle at initial contact while landing from a jump |
| Walking Loading Rate Immediately Post Intervention | 24-72 hours post intervention | Rate of weight acceptance while walking |
| Landing Ankle Dorsiflexion Immediately Post Intervention | 24-72 hours post intervention | Dorsiflexion angle of the ankle at initial contact while landing from a jump |
| Walking Loading Rate at Baseline | Baseline | Rate of weight acceptance while walking |
| Walking Ankle Dorsiflexion at 4-weeks Post Intervention | 4-weeks post intervention | Dorsiflexion angle of the ankle at initial contact while walking. |
| Walking Ankle Dorsiflexion Immediately Post Intervention | 24-72 hours post intervention | Dorsiflexion angle of the ankle at initial contact while walking. |
| Walking Ankle Dorsiflexion at Baseline | Baseline | Dorsiflexion angle of the ankle at initial contact while walking. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control group that will receive no intervention throughout the duration of the study (2-weeks). | 20 |
| Joint Mobilization Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. | 20 |
| Massage Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Control | Joint Mobilization | Massage | Total |
|---|---|---|---|---|
| Age, Continuous | 19.5 years STANDARD_DEVIATION 0.8 | 21.9 years STANDARD_DEVIATION 3.9 | 20.9 years STANDARD_DEVIATION 3.2 | 20.7 years STANDARD_DEVIATION 3.1 |
| Ankle Instability Instrument | 7.4 units on a scale STANDARD_DEVIATION 1.35 | 7.4 units on a scale STANDARD_DEVIATION 1.46 | 7.0 units on a scale STANDARD_DEVIATION 1.23 | 7.3 units on a scale STANDARD_DEVIATION 1.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 17 Participants | 18 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of ankle sprains | 4.5 sprains STANDARD_DEVIATION 3.5 | 4.25 sprains STANDARD_DEVIATION 2.35 | 5.1 sprains STANDARD_DEVIATION 3.85 | 4.6 sprains STANDARD_DEVIATION 3.27 |
| Number of giving way episodes | 7 giving way episodes STANDARD_DEVIATION 1.56 | 10.4 giving way episodes STANDARD_DEVIATION 16.13 | 9.15 giving way episodes STANDARD_DEVIATION 8.63 | 8.85 giving way episodes STANDARD_DEVIATION 11.2 |
| Outcome Expectations for Exercise Scale | 2.8 units on a scale STANDARD_DEVIATION 0.83 | 2.8 units on a scale STANDARD_DEVIATION 0.76 | 2.9 units on a scale STANDARD_DEVIATION 0.85 | 2.83 units on a scale STANDARD_DEVIATION 0.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 17 Participants | 14 Participants | 46 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 8 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
95% Confidence Ellipse From Baseline to Follow-Up
% Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 4-week Follow-Up
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | 95% Confidence Ellipse From Baseline to Follow-Up | Baseline | 286.29 % modulation | Standard Deviation 173.43 |
| Control | 95% Confidence Ellipse From Baseline to Follow-Up | Follow-Up | 317.46 % modulation | Standard Deviation 146.05 |
| Joint Mobilization | 95% Confidence Ellipse From Baseline to Follow-Up | Baseline | 272.07 % modulation | Standard Deviation 142.18 |
| Joint Mobilization | 95% Confidence Ellipse From Baseline to Follow-Up | Follow-Up | 254.06 % modulation | Standard Deviation 165.9 |
| Massage | 95% Confidence Ellipse From Baseline to Follow-Up | Baseline | 282.06 % modulation | Standard Deviation 129.6 |
| Massage | 95% Confidence Ellipse From Baseline to Follow-Up | Follow-Up | 267.92 % modulation | Standard Deviation 134.57 |
p-value: 0.535ANOVA
p-value: 0.569ANOVA
Primary
95% Confidence Ellipse From Baseline to Post Intervention
% Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | 95% Confidence Ellipse From Baseline to Post Intervention | Baseline | 270.91 % modulation | Standard Deviation 168.28 |
| Control | 95% Confidence Ellipse From Baseline to Post Intervention | Post-Intervention | 267.85 % modulation | Standard Deviation 127.6 |
| Joint Mobilization | 95% Confidence Ellipse From Baseline to Post Intervention | Baseline | 270.91 % modulation | Standard Deviation 168.28 |
| Joint Mobilization | 95% Confidence Ellipse From Baseline to Post Intervention | Post-Intervention | 283.26 % modulation | Standard Deviation 111.89 |
| Massage | 95% Confidence Ellipse From Baseline to Post Intervention | Baseline | 290.70 % modulation | Standard Deviation 128.07 |
| Massage | 95% Confidence Ellipse From Baseline to Post Intervention | Post-Intervention | 275.92 % modulation | Standard Deviation 142.78 |
p-value: 0.849ANOVA
p-value: 0.993ANOVA
Primary
AP COP Velocity From Baseline to Follow-up
% Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | AP COP Velocity From Baseline to Follow-up | Baseline | 119.48 % modulation | Standard Deviation 33.02 |
| Control | AP COP Velocity From Baseline to Follow-up | Follow-Up | 117.67 % modulation | Standard Deviation 40.04 |
| Joint Mobilization | AP COP Velocity From Baseline to Follow-up | Baseline | 116.69 % modulation | Standard Deviation 48.19 |
| Joint Mobilization | AP COP Velocity From Baseline to Follow-up | Follow-Up | 105.10 % modulation | Standard Deviation 48.54 |
| Massage | AP COP Velocity From Baseline to Follow-up | Baseline | 123.93 % modulation | Standard Deviation 39.4 |
| Massage | AP COP Velocity From Baseline to Follow-up | Follow-Up | 97.96 % modulation | Standard Deviation 35.18 |
p-value: 0.138ANOVA
p-value: 0.523ANOVA
Primary
AP COP Velocity From Baseline to Post Intervention
% Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | AP COP Velocity From Baseline to Post Intervention | Baseline | 117.40 % modulation | Standard Deviation 31.73 |
| Control | AP COP Velocity From Baseline to Post Intervention | Post Intervention | 120.91 % modulation | Standard Deviation 33.69 |
| Joint Mobilization | AP COP Velocity From Baseline to Post Intervention | Baseline | 115.84 % modulation | Standard Deviation 47.32 |
| Joint Mobilization | AP COP Velocity From Baseline to Post Intervention | Post Intervention | 122.51 % modulation | Standard Deviation 39.05 |
| Massage | AP COP Velocity From Baseline to Post Intervention | Baseline | 126.50 % modulation | Standard Deviation 37.95 |
| Massage | AP COP Velocity From Baseline to Post Intervention | Post Intervention | 100.91 % modulation | Standard Deviation 38.53 |
p-value: 0.046ANOVA
p-value: 0.845ANOVA
Primary
AP TTB From Baseline to Follow-Up
% Modulation of AP Time-to-Boundary. First, time-to-Boundary is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
Time frame: Baseline and 4-week Follow-Up
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | AP TTB From Baseline to Follow-Up | Baseline | -52.95 % modulation | Standard Deviation 10.4 |
| Control | AP TTB From Baseline to Follow-Up | Follow-Up | -51.94 % modulation | Standard Deviation 11.4 |
| Joint Mobilization | AP TTB From Baseline to Follow-Up | Baseline | -55.09 % modulation | Standard Deviation 8.36 |
| Joint Mobilization | AP TTB From Baseline to Follow-Up | Follow-Up | -47.38 % modulation | Standard Deviation 12.05 |
| Massage | AP TTB From Baseline to Follow-Up | Baseline | -53.98 % modulation | Standard Deviation 10.53 |
| Massage | AP TTB From Baseline to Follow-Up | Follow-Up | -48.81 % modulation | Standard Deviation 9.92 |
p-value: 0.142ANOVA
p-value: 0.167ANOVA
Primary
AP TTB From Baseline to Post Intervention
% Modulation of AP Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
Time frame: Baseline and 24-72 hours post intervention
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | AP TTB From Baseline to Post Intervention | Baseline | -52.54 % modulation | Standard Deviation 9.67 |
| Control | AP TTB From Baseline to Post Intervention | Post Intervention | -52.97 % modulation | Standard Deviation 7.31 |
| Joint Mobilization | AP TTB From Baseline to Post Intervention | Baseline | -54.59 % modulation | Standard Deviation 8.81 |
| Joint Mobilization | AP TTB From Baseline to Post Intervention | Post Intervention | -54.39 % modulation | Standard Deviation 11.01 |
| Massage | AP TTB From Baseline to Post Intervention | Baseline | -57.53 % modulation | Standard Deviation 8.24 |
| Massage | AP TTB From Baseline to Post Intervention | Post Intervention | -48.81 % modulation | Standard Deviation 8.67 |
p-value: 0.005ANOVA
p-value: 0.853ANOVA
Primary
ML COP Velocity From Baseline to Follow-Up
% Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the Follow-Up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | ML COP Velocity From Baseline to Follow-Up | Baseline | 119.71 % modulation | Standard Deviation 48.7 |
| Control | ML COP Velocity From Baseline to Follow-Up | Follow-Up | 118.86 % modulation | Standard Deviation 45.11 |
| Joint Mobilization | ML COP Velocity From Baseline to Follow-Up | Baseline | 116.13 % modulation | Standard Deviation 41.37 |
| Joint Mobilization | ML COP Velocity From Baseline to Follow-Up | Follow-Up | 110.80 % modulation | Standard Deviation 46.45 |
| Massage | ML COP Velocity From Baseline to Follow-Up | Baseline | 119.14 % modulation | Standard Deviation 46.66 |
| Massage | ML COP Velocity From Baseline to Follow-Up | Follow-Up | 111.06 % modulation | Standard Deviation 43.86 |
p-value: 0.722ANOVA
p-value: 0.843ANOVA
Primary
ML COP Velocity From Baseline to Post Intervention
% Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | ML COP Velocity From Baseline to Post Intervention | Baseline | 119.91 % modulation | Standard Deviation 47.38 |
| Control | ML COP Velocity From Baseline to Post Intervention | Post Intervention | 116.99 % modulation | Standard Deviation 36.16 |
| Joint Mobilization | ML COP Velocity From Baseline to Post Intervention | Baseline | 118.91 % modulation | Standard Deviation 47.38 |
| Joint Mobilization | ML COP Velocity From Baseline to Post Intervention | Post Intervention | 128.23 % modulation | Standard Deviation 40.1 |
| Massage | ML COP Velocity From Baseline to Post Intervention | Baseline | 121.07 % modulation | Standard Deviation 44.55 |
| Massage | ML COP Velocity From Baseline to Post Intervention | Post Intervention | 121.20 % modulation | Standard Deviation 42.83 |
p-value: 0.824ANOVA
p-value: 0.426ANOVA
Primary
ML TTB From Baseline to Follow-Up
% Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data was due to participants lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | ML TTB From Baseline to Follow-Up | Baseline | -48.98 % modulation | Standard Deviation 14.31 |
| Control | ML TTB From Baseline to Follow-Up | Follow-Up | -51.12 % modulation | Standard Deviation 13 |
| Joint Mobilization | ML TTB From Baseline to Follow-Up | Baseline | -54.18 % modulation | Standard Deviation 9.41 |
| Joint Mobilization | ML TTB From Baseline to Follow-Up | Follow-Up | -52.18 % modulation | Standard Deviation 12.69 |
| Massage | ML TTB From Baseline to Follow-Up | Baseline | -51.12 % modulation | Standard Deviation 13 |
| Massage | ML TTB From Baseline to Follow-Up | Follow-Up | -53.12 % modulation | Standard Deviation 10.91 |
p-value: 0.604ANOVA
p-value: 0.499ANOVA
Primary
ML TTB From Baseline to Post Intervention
% Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
Time frame: Baseline and 24-72 hours post intervention
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | ML TTB From Baseline to Post Intervention | Baseline | -50.76 % modulation | Standard Deviation 13.41 |
| Control | ML TTB From Baseline to Post Intervention | Post Intervention | -55.99 % modulation | Standard Deviation 7.14 |
| Joint Mobilization | ML TTB From Baseline to Post Intervention | Baseline | -54.97 % modulation | Standard Deviation 8.98 |
| Joint Mobilization | ML TTB From Baseline to Post Intervention | Post Intervention | -56.61 % modulation | Standard Deviation 10.43 |
| Massage | ML TTB From Baseline to Post Intervention | Baseline | -55.41 % modulation | Standard Deviation 10.81 |
| Massage | ML TTB From Baseline to Post Intervention | Post Intervention | -52.28 % modulation | Standard Deviation 11.73 |
p-value: 0.069ANOVA
p-value: 0.413ANOVA
Secondary
1st Metatarsal Light-touch Threshold From Baseline to Follow-Up
Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants being lost at follow up.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control | 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline | 2.95 mm | Standard Deviation 0.67 |
| Control | 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Follow-Up | 3.22 mm | Standard Deviation 0.67 |
| Joint Mobilization | 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline | 3.22 mm | Standard Deviation 0.57 |
| Joint Mobilization | 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Follow-Up | 3.22 mm | Standard Deviation 0.58 |
| Massage | 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline | 3.41 mm | Standard Deviation 0.77 |
| Massage | 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up | Follow-Up | 2.83 mm | Standard Deviation 0.81 |
p-value: 0.925Independent sample Mann-Whitney U
Secondary
1st Metatarsal Light-touch Threshold From Baseline to Post Intervention
Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. his analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants being lost at follow up.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control | 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline | 2.83 mm | Standard Deviation 0.62 |
| Control | 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Post intervention | 3.41 mm | Standard Deviation 0.57 |
| Joint Mobilization | 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline | 3.22 mm | Standard Deviation 0.55 |
| Joint Mobilization | 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Post intervention | 3.22 mm | Standard Deviation 0.73 |
| Massage | 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline | 3.61 mm | Standard Deviation 0.76 |
| Massage | 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention | Post intervention | 2.83 mm | Standard Deviation 0.54 |
p-value: 0.613Independent sample Mann-Whitney U
Secondary
5th Metatarsal Light-touch Threshold From Baseline to Follow-Up
Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow Up
Population: Missing data due to participants being lost at follow up.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control | 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline | 3.22 mm | Standard Deviation 0.62 |
| Control | 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Follow-Up | 3.61 mm | Standard Deviation 0.5 |
| Joint Mobilization | 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline | 3.22 mm | Standard Deviation 0.61 |
| Joint Mobilization | 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Follow-Up | 3.41 mm | Standard Deviation 0.85 |
| Massage | 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Follow-Up | 3.61 mm | Standard Deviation 0.91 |
| Massage | 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up | Baseline | 3.84 mm | Standard Deviation 0.76 |
p-value: 0.561Wilcoxon (Mann-Whitney)
p-value: 0.925Wilcoxon (Mann-Whitney)
Secondary
5th Metatarsal Light-touch Threshold From Baseline to Post Intervention
Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants being lost at follow up.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control | 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline | 3.22 mm | Standard Deviation 0.6 |
| Control | 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Post Intervention | 3.61 mm | Standard Deviation 0.69 |
| Joint Mobilization | 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline | 3.22 mm | Standard Deviation 0.59 |
| Joint Mobilization | 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Post Intervention | 3.41 mm | Standard Deviation 0.23 |
| Massage | 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Baseline | 3.84 mm | Standard Deviation 0.75 |
| Massage | 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention | Post Intervention | 3.22 mm | Standard Deviation 0.69 |
p-value: 0.641Wilcoxon (Mann-Whitney)
p-value: 0.897Wilcoxon (Mann-Whitney)
Secondary
Alpha Power Spectral Density From Baseline to Follow-Up
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost at follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Alpha Power Spectral Density From Baseline to Follow-Up | Baseline | 0.669 mV | Standard Deviation 0.373 |
| Control | Alpha Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.718 mV | Standard Deviation 0.398 |
| Joint Mobilization | Alpha Power Spectral Density From Baseline to Follow-Up | Baseline | 0.896 mV | Standard Deviation 0.673 |
| Joint Mobilization | Alpha Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.805 mV | Standard Deviation 0.471 |
| Massage | Alpha Power Spectral Density From Baseline to Follow-Up | Baseline | 0.707 mV | Standard Deviation 0.425 |
| Massage | Alpha Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.701 mV | Standard Deviation 0.441 |
p-value: 0.777ANOVA
p-value: 0.475ANOVA
Secondary
Alpha Power Spectral Density From Baseline to Post Intervention
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Alpha Power Spectral Density From Baseline to Post Intervention | Baseline | 0.739 mV | Standard Deviation 0.479 |
| Control | Alpha Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.731 mV | Standard Deviation 0.477 |
| Joint Mobilization | Alpha Power Spectral Density From Baseline to Post Intervention | Baseline | 0.911 mV | Standard Deviation 0.686 |
| Joint Mobilization | Alpha Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.990 mV | Standard Deviation 0.887 |
| Massage | Alpha Power Spectral Density From Baseline to Post Intervention | Baseline | 0.755 mV | Standard Deviation 0.428 |
| Massage | Alpha Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.633 mV | Standard Deviation 0.272 |
p-value: 0.506ANOVA
p-value: 0.753ANOVA
Secondary
Beta Power Spectral Density From Baseline to Follow-Up
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost at follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Beta Power Spectral Density From Baseline to Follow-Up | Baseline | 0.310 mV | Standard Deviation 0.104 |
| Control | Beta Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.309 mV | Standard Deviation 0.08 |
| Joint Mobilization | Beta Power Spectral Density From Baseline to Follow-Up | Baseline | 0.442 mV | Standard Deviation 0.169 |
| Joint Mobilization | Beta Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.429 mV | Standard Deviation 0.169 |
| Massage | Beta Power Spectral Density From Baseline to Follow-Up | Baseline | 0.338 mV | Standard Deviation 0.206 |
| Massage | Beta Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.311 mV | Standard Deviation 0.14 |
p-value: 0.738ANOVA
p-value: 0.83ANOVA
Secondary
Beta Power Spectral Density From Baseline to Post Intervention
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Beta Power Spectral Density From Baseline to Post Intervention | Baseline | 0.355 mV | Standard Deviation 0.147 |
| Control | Beta Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.336 mV | Standard Deviation 0.125 |
| Joint Mobilization | Beta Power Spectral Density From Baseline to Post Intervention | Baseline | 0.480 mV | Standard Deviation 0.285 |
| Joint Mobilization | Beta Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.600 mV | Standard Deviation 0.33 |
| Massage | Beta Power Spectral Density From Baseline to Post Intervention | Baseline | 0.361 mV | Standard Deviation 0.2 |
| Massage | Beta Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.354 mV | Standard Deviation 0.162 |
p-value: 0.738ANOVA
p-value: 0.042ANOVA
Secondary
Cortical Silent Period From Baseline to Follow-Up
A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Cortical Silent Period From Baseline to Follow-Up | Baseline | 0.088 ms | Standard Deviation 0.037 |
| Control | Cortical Silent Period From Baseline to Follow-Up | Follow Up | 0.088 ms | Standard Deviation 0.024 |
| Joint Mobilization | Cortical Silent Period From Baseline to Follow-Up | Baseline | 0.121 ms | Standard Deviation 0.087 |
| Joint Mobilization | Cortical Silent Period From Baseline to Follow-Up | Follow Up | 0.096 ms | Standard Deviation 0.024 |
| Massage | Cortical Silent Period From Baseline to Follow-Up | Baseline | 0.114 ms | Standard Deviation 0.032 |
| Massage | Cortical Silent Period From Baseline to Follow-Up | Follow Up | 0.110 ms | Standard Deviation 0.046 |
p-value: 0.883ANOVA
p-value: 0.401ANOVA
Secondary
Cortical Silent Period From Baseline to Post Intervention
A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Cortical Silent Period From Baseline to Post Intervention | Baseline | 0.107 ms | Standard Deviation 0.077 |
| Control | Cortical Silent Period From Baseline to Post Intervention | Post-Intervention | 0.085 ms | Standard Deviation 0.036 |
| Joint Mobilization | Cortical Silent Period From Baseline to Post Intervention | Baseline | 0.125 ms | Standard Deviation 0.084 |
| Joint Mobilization | Cortical Silent Period From Baseline to Post Intervention | Post-Intervention | 0.114 ms | Standard Deviation 0.038 |
| Massage | Cortical Silent Period From Baseline to Post Intervention | Baseline | 0.122 ms | Standard Deviation 0.027 |
| Massage | Cortical Silent Period From Baseline to Post Intervention | Post-Intervention | 0.091 ms | Standard Deviation 0.024 |
p-value: 0.701ANOVA
p-value: 0.68ANOVA
Secondary
Corticomotor Map Area From Baseline to Follow-Up
A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost at follow-up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Corticomotor Map Area From Baseline to Follow-Up | Baseline | 14.3 number of positions | Standard Deviation 11.79 |
| Control | Corticomotor Map Area From Baseline to Follow-Up | Follow Up | 9.08 number of positions | Standard Deviation 6.17 |
| Joint Mobilization | Corticomotor Map Area From Baseline to Follow-Up | Baseline | 16.73 number of positions | Standard Deviation 10.1 |
| Joint Mobilization | Corticomotor Map Area From Baseline to Follow-Up | Follow Up | 16.73 number of positions | Standard Deviation 6.73 |
| Massage | Corticomotor Map Area From Baseline to Follow-Up | Baseline | 20.0 number of positions | Standard Deviation 12.92 |
| Massage | Corticomotor Map Area From Baseline to Follow-Up | Follow Up | 20.66 number of positions | Standard Deviation 12.92 |
p-value: 0.246ANOVA
p-value: 0.191ANOVA
Secondary
Corticomotor Map Area From Baseline to Post Intervention
A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Corticomotor Map Area From Baseline to Post Intervention | Baseline | 13.43 number of positions | Standard Deviation 10.6 |
| Control | Corticomotor Map Area From Baseline to Post Intervention | Post-Intervention | 16.68 number of positions | Standard Deviation 11.47 |
| Joint Mobilization | Corticomotor Map Area From Baseline to Post Intervention | Baseline | 19.6 number of positions | Standard Deviation 12 |
| Joint Mobilization | Corticomotor Map Area From Baseline to Post Intervention | Post-Intervention | 21.55 number of positions | Standard Deviation 11.4 |
| Massage | Corticomotor Map Area From Baseline to Post Intervention | Post-Intervention | 20.2 number of positions | Standard Deviation 12.14 |
| Massage | Corticomotor Map Area From Baseline to Post Intervention | Baseline | 21.8 number of positions | Standard Deviation 15.3 |
p-value: 0.393ANOVA
p-value: 0.779ANOVA
Secondary
Corticomotor Map Volume From Baseline to Follow-Up
measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost at follow-up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Corticomotor Map Volume From Baseline to Follow-Up | Baseline | 0.91 number of positions | Standard Deviation 0.32 |
| Control | Corticomotor Map Volume From Baseline to Follow-Up | Follow-Up | 0.66 number of positions | Standard Deviation 0.39 |
| Joint Mobilization | Corticomotor Map Volume From Baseline to Follow-Up | Baseline | 1.12 number of positions | Standard Deviation 0.62 |
| Joint Mobilization | Corticomotor Map Volume From Baseline to Follow-Up | Follow-Up | 0.74 number of positions | Standard Deviation 0.16 |
| Massage | Corticomotor Map Volume From Baseline to Follow-Up | Baseline | 0.99 number of positions | Standard Deviation 0.5 |
| Massage | Corticomotor Map Volume From Baseline to Follow-Up | Follow-Up | 0.72 number of positions | Standard Deviation 0.35 |
p-value: 0.925ANOVA
p-value: 0.551ANOVA
Secondary
Corticomotor Map Volume From Baseline to Post Intervention
A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Corticomotor Map Volume From Baseline to Post Intervention | Baseline | 0.89 number of positions | Standard Deviation 0.29 |
| Control | Corticomotor Map Volume From Baseline to Post Intervention | Post-Intervention | 0.80 number of positions | Standard Deviation 0.36 |
| Joint Mobilization | Corticomotor Map Volume From Baseline to Post Intervention | Baseline | 1.2 number of positions | Standard Deviation 0.6 |
| Joint Mobilization | Corticomotor Map Volume From Baseline to Post Intervention | Post-Intervention | 0.93 number of positions | Standard Deviation 0.23 |
| Massage | Corticomotor Map Volume From Baseline to Post Intervention | Baseline | 1.07 number of positions | Standard Deviation 0.72 |
| Massage | Corticomotor Map Volume From Baseline to Post Intervention | Post-Intervention | 1.05 number of positions | Standard Deviation 0.89 |
p-value: 0.703ANOVA
p-value: 0.282ANOVA
Secondary
Fibularis Longus Active Motor Threshold From Baseline to Follow-Up
A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Baseline | 44 % maximum intensity | Standard Deviation 10.23 |
| Control | Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Follow-Up | 44.75 % maximum intensity | Standard Deviation 9.16 |
| Joint Mobilization | Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Baseline | 39.6 % maximum intensity | Standard Deviation 8.47 |
| Joint Mobilization | Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Follow-Up | 40.26 % maximum intensity | Standard Deviation 9.26 |
| Massage | Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Baseline | 41.22 % maximum intensity | Standard Deviation 6.9 |
| Massage | Fibularis Longus Active Motor Threshold From Baseline to Follow-Up | Follow-Up | 42.55 % maximum intensity | Standard Deviation 43.8 |
p-value: 0.796ANOVA
p-value: 0.558ANOVA
Secondary
Fibularis Longus Active Motor Threshold From Baseline to Post Intervention
A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants being lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Baseline | 44 % maximum intensity | Standard Deviation 9.87 |
| Control | Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Post-Intervention | 45.12 % maximum intensity | Standard Deviation 8.37 |
| Joint Mobilization | Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Baseline | 38.38 % maximum intensity | Standard Deviation 8.6 |
| Joint Mobilization | Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Post-Intervention | 38.27 % maximum intensity | Standard Deviation 6.75 |
| Massage | Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Baseline | 40.8 % maximum intensity | Standard Deviation 42.2 |
| Massage | Fibularis Longus Active Motor Threshold From Baseline to Post Intervention | Post-Intervention | 42.2 % maximum intensity | Standard Deviation 8.46 |
p-value: 0.919ANOVA
p-value: 0.558ANOVA
Secondary
Fibularis Longus H:M Ratio From Baseline to Follow-Up
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants being lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Fibularis Longus H:M Ratio From Baseline to Follow-Up | Baseline | 0.30 H:M Ratio | Standard Deviation 0.08 |
| Control | Fibularis Longus H:M Ratio From Baseline to Follow-Up | Follow-Up | 0.29 H:M Ratio | Standard Deviation 0.14 |
| Joint Mobilization | Fibularis Longus H:M Ratio From Baseline to Follow-Up | Baseline | 0.28 H:M Ratio | Standard Deviation 0.2 |
| Joint Mobilization | Fibularis Longus H:M Ratio From Baseline to Follow-Up | Follow-Up | 0.23 H:M Ratio | Standard Deviation 0.11 |
| Massage | Fibularis Longus H:M Ratio From Baseline to Follow-Up | Baseline | 0.28 H:M Ratio | Standard Deviation 0.2 |
| Massage | Fibularis Longus H:M Ratio From Baseline to Follow-Up | Follow-Up | 0.32 H:M Ratio | Standard Deviation 0.18 |
p-value: 0.456ANOVA
p-value: 0.568ANOVA
Secondary
Fibularis Longus H:M Ratio From Baseline to Post Intervention
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants being lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Fibularis Longus H:M Ratio From Baseline to Post Intervention | Baseline | 0.34 H:M Ratio | Standard Deviation 0.13 |
| Control | Fibularis Longus H:M Ratio From Baseline to Post Intervention | Post-Intervention | 0.27 H:M Ratio | Standard Deviation 0.08 |
| Joint Mobilization | Fibularis Longus H:M Ratio From Baseline to Post Intervention | Baseline | 0.29 H:M Ratio | Standard Deviation 0.2 |
| Joint Mobilization | Fibularis Longus H:M Ratio From Baseline to Post Intervention | Post-Intervention | 0.23 H:M Ratio | Standard Deviation 0.12 |
| Massage | Fibularis Longus H:M Ratio From Baseline to Post Intervention | Baseline | 0.25 H:M Ratio | Standard Deviation 0.2 |
| Massage | Fibularis Longus H:M Ratio From Baseline to Post Intervention | Post-Intervention | 0.28 H:M Ratio | Standard Deviation 0.17 |
p-value: 0.03ANOVA
p-value: 0.618ANOVA
Secondary
Gamma Power Spectral Density From Baseline to Follow-Up
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants lost at follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Gamma Power Spectral Density From Baseline to Follow-Up | Baseline | 0.109 mV | Standard Deviation 0.029 |
| Control | Gamma Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.116 mV | Standard Deviation 0.036 |
| Joint Mobilization | Gamma Power Spectral Density From Baseline to Follow-Up | Baseline | 0.149 mV | Standard Deviation 0.062 |
| Joint Mobilization | Gamma Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.166 mV | Standard Deviation 0.072 |
| Massage | Gamma Power Spectral Density From Baseline to Follow-Up | Baseline | 0.120 mV | Standard Deviation 0.048 |
| Massage | Gamma Power Spectral Density From Baseline to Follow-Up | Follow-Up | 0.123 mV | Standard Deviation 0.041 |
p-value: 0.82ANOVA
p-value: 0.526ANOVA
Secondary
Gamma Power Spectral Density From Baseline to Post Intervention
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Gamma Power Spectral Density From Baseline to Post Intervention | Baseline | 0.116 mV | Standard Deviation 0.046 |
| Control | Gamma Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.123 mV | Standard Deviation 0.041 |
| Joint Mobilization | Gamma Power Spectral Density From Baseline to Post Intervention | Baseline | 0.155 mV | Standard Deviation 0.063 |
| Joint Mobilization | Gamma Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.172 mV | Standard Deviation 0.097 |
| Massage | Gamma Power Spectral Density From Baseline to Post Intervention | Baseline | 0.123 mV | Standard Deviation 0.052 |
| Massage | Gamma Power Spectral Density From Baseline to Post Intervention | Post Intervention | 0.125 mV | Standard Deviation 0.047 |
p-value: 0.7ANOVA
p-value: 0.492ANOVA
Secondary
Plantar Flexion Joint Position Sense From Baseline to Follow-Up
Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the follow-up assessment.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data was due to participants being lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Baseline | 3.04 Degrees | Standard Deviation 1.78 |
| Control | Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Follow-Up | 2.35 Degrees | Standard Deviation 1.95 |
| Joint Mobilization | Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Baseline | 3.04 Degrees | Standard Deviation 1.78 |
| Joint Mobilization | Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Follow-Up | 1.51 Degrees | Standard Deviation 1.49 |
| Massage | Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Baseline | 3.72 Degrees | Standard Deviation 2.61 |
| Massage | Plantar Flexion Joint Position Sense From Baseline to Follow-Up | Follow-Up | 2.62 Degrees | Standard Deviation 2.2 |
p-value: 0.609ANOVA
p-value: 0.027ANOVA
Secondary
Plantar Flexion Joint Position Sense From Baseline to Post Intervention
Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the immediate post-treatment assessment.
Time frame: Baseline and 24-72 hours post intervention
Population: All missing data was the result of participants being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Baseline | 3.00 Degrees | Standard Deviation 1.82 |
| Control | Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Post Intervention | 2.22 Degrees | Standard Deviation 1.36 |
| Joint Mobilization | Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Baseline | 3.25 Degrees | Standard Deviation 1.6 |
| Joint Mobilization | Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Post Intervention | 1.97 Degrees | Standard Deviation 1.54 |
| Massage | Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Baseline | 3.73 Degrees | Standard Deviation 2.54 |
| Massage | Plantar Flexion Joint Position Sense From Baseline to Post Intervention | Post Intervention | 2.42 Degrees | Standard Deviation 1.67 |
p-value: 0.405ANOVA
p-value: 0.229ANOVA
Secondary
Soleus H:M Ratio From Baseline to Follow-Up
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Time frame: Baseline and 4-week Follow-Up
Population: Missing data due to participants being lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Soleus H:M Ratio From Baseline to Follow-Up | Baseline | 0.67 H:M Ratio | Standard Deviation 0.15 |
| Control | Soleus H:M Ratio From Baseline to Follow-Up | Follow-Up | 0.64 H:M Ratio | Standard Deviation 0.13 |
| Joint Mobilization | Soleus H:M Ratio From Baseline to Follow-Up | Baseline | 0.63 H:M Ratio | Standard Deviation 0.18 |
| Joint Mobilization | Soleus H:M Ratio From Baseline to Follow-Up | Follow-Up | 0.62 H:M Ratio | Standard Deviation 0.16 |
| Massage | Soleus H:M Ratio From Baseline to Follow-Up | Baseline | 0.65 H:M Ratio | Standard Deviation 0.25 |
| Massage | Soleus H:M Ratio From Baseline to Follow-Up | Follow-Up | 0.67 H:M Ratio | Standard Deviation 0.15 |
p-value: 0.233ANOVA
p-value: 0.634ANOVA
Secondary
Soleus H:M Ratio From Baseline to Post Intervention
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Time frame: Baseline and 24-72 hours post intervention
Population: Missing data due to participants being lost to follow up or technical issues with equipment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Soleus H:M Ratio From Baseline to Post Intervention | Baseline | 0.68 H:M Ratio | Standard Deviation 0.14 |
| Control | Soleus H:M Ratio From Baseline to Post Intervention | Post-Intervention | 0.67 H:M Ratio | Standard Deviation 0.14 |
| Joint Mobilization | Soleus H:M Ratio From Baseline to Post Intervention | Baseline | 0.65 H:M Ratio | Standard Deviation 0.18 |
| Joint Mobilization | Soleus H:M Ratio From Baseline to Post Intervention | Post-Intervention | 0.62 H:M Ratio | Standard Deviation 0.12 |
| Massage | Soleus H:M Ratio From Baseline to Post Intervention | Baseline | 0.63 H:M Ratio | Standard Deviation 0.3 |
| Massage | Soleus H:M Ratio From Baseline to Post Intervention | Post-Intervention | 0.64 H:M Ratio | Standard Deviation 0.29 |
p-value: 0.233ANOVA
p-value: 0.634ANOVA
Other Pre-specified
Landing Ankle Dorsiflexion at 4-weeks Post Intervention
Dorsiflexion angle of the ankle at initial contact while landing from a jump
Time frame: 4-weeks post intervention
Other Pre-specified
Landing Ankle Dorsiflexion at Baseline
Dorsiflexion angle of the ankle at initial contact while landing from a jump
Time frame: Baseline
Other Pre-specified
Landing Ankle Dorsiflexion Immediately Post Intervention
Dorsiflexion angle of the ankle at initial contact while landing from a jump
Time frame: 24-72 hours post intervention
Other Pre-specified
Landing Loading Rate at 4-weeks Post Intervention
Rate of weight acceptance while landing from a jump
Time frame: 4-weeks post intervention
Other Pre-specified
Landing Loading Rate at Baseline
Rate of weight acceptance while landing from a jump
Time frame: Baseline
Other Pre-specified
Landing Loading Rate Immediately Post Intervention
Rate of weight acceptance while landing from a jump
Time frame: 24-72 hours post intervention
Other Pre-specified
Walking Ankle Dorsiflexion at 4-weeks Post Intervention
Dorsiflexion angle of the ankle at initial contact while walking.
Time frame: 4-weeks post intervention
Other Pre-specified
Walking Ankle Dorsiflexion at Baseline
Dorsiflexion angle of the ankle at initial contact while walking.
Time frame: Baseline
Other Pre-specified
Walking Ankle Dorsiflexion Immediately Post Intervention
Dorsiflexion angle of the ankle at initial contact while walking.
Time frame: 24-72 hours post intervention
Other Pre-specified
Walking Loading Rate at 4-weeks Post Intervention
Rate of weight acceptance while walking
Time frame: 4-weeks post intervention
Other Pre-specified
Walking Loading Rate at Baseline
Rate of weight acceptance while walking
Time frame: Baseline
Other Pre-specified
Walking Loading Rate Immediately Post Intervention
Rate of weight acceptance while walking
Time frame: 24-72 hours post intervention