Adult ALL, Healthy
Conditions
Keywords
Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics
Brief summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Detailed description
The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses. Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded. The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis
Interventions
The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the different design variations of each device, and will only be introduced to each device as CDO-A, CDO-B or CDO-C.
Intervention model description
All participants will use three generic sized carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 18 and 50 * Shoe size between women's 8 and 13.5 or men's 6.5 and 12 * Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months * Full active range of motion of the bilateral lower extremities and spine * Ability to hop without pain * Ability to perform a full squat without pain * Ability to read and write in English and provide written informed consent
Exclusion criteria
* Diagnosed moderate or severe brain injury * Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks * Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Visual or hearing impairment that would interfere with instructions given during testing * Require an assistive device * Wounds to the foot or calf that would prevent CDO use * BMI greater than 35 * Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint Contact Stress-Time Exposure | Baseline | Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Range of Motion | Baseline | Peak dorsiflexion angle (degrees) during gait. |
| Peak Ankle Moment | Baseline | Peak ankle moment (Nm/kg) during gait. |
| Peak Ankle Power | Baseline | Peak ankle power (W/kg) during gait. |
| Plantar Force (Total Foot) | Baseline | Force data (N) collected across the total foot measured between the foot and orthosis during gait. |
| Plantar Force (Forefoot) | Baseline | Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait. |
| Plantar Force (Midfoot) | Baseline | Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait. |
| Plantar Force (Hindfoot) | Baseline | Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait. |
| Four Square Step Test (4SST) | Baseline | The 4SST (s) is a standardized timed test of balance and agility. |
| Sit to Stand 5 Times (STS5) | Baseline | STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible. |
| Numerical Pain Rating Scale | Baseline | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. |
| The Orthotics Prosthetics Users' Survey (OPUS) | Baseline | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0. |
| Soleus Muscle Force (N) | Baseline | Peak Soleus muscle forces (N) will be estimated using an Opensim model |
| Gastrocnemius Muscle Force (N) | Baseline | Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model |
| Modified Socket Comfort Score (Comfort) | Baseline | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. |
| Modified Socket Comfort Score (Smoothness) | Baseline | Comfort scores range from 0 = least smooth to 10 = most smooth. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason M Wilken, PT, PhD
University of Iowa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NoCDO, CDOA, CDOB, CDOC Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 0 |
| NoCDO, CDOA, CDOC, CDOB Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 4 |
| NoCDO, CDOB, CDOA, CDOC Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 1 |
| NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 1 |
| NoCDO, CDOC, CDOA, CDOB Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 2 |
| NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 1 |
| Total | 9 |
Baseline characteristics
| Characteristic | NoCDO, CDOB, CDOA, CDOC | NoCDO, CDOB, CDOC, CDOA | NoCDO, CDOC, CDOA, CDOB | NoCDO, CDOC, CDOB, CDOA | Total | NoCDO, CDOA, CDOC, CDOB | NoCDO, CDOA, CDOB, CDOC |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 23.0 years STANDARD_DEVIATION 0 | 22.0 years STANDARD_DEVIATION 0 | 22.5 years STANDARD_DEVIATION 0.7 | 19.0 years STANDARD_DEVIATION 0 | 21.8 years STANDARD_DEVIATION 1.7 | 21.8 years STANDARD_DEVIATION 2.1 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 9 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Joint Contact Stress-Time Exposure
Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Joint Contact Stress-Time Exposure | 3.9 MPa-s/gait cycle | Standard Deviation 2.9 |
| CDOA | Joint Contact Stress-Time Exposure | 3.5 MPa-s/gait cycle | Standard Deviation 2.7 |
| CDOB | Joint Contact Stress-Time Exposure | 4.1 MPa-s/gait cycle | Standard Deviation 2.9 |
| CDOC | Joint Contact Stress-Time Exposure | 2.7 MPa-s/gait cycle | Standard Deviation 0.6 |
Secondary
Ankle Range of Motion
Peak dorsiflexion angle (degrees) during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Ankle Range of Motion | 17.8 degrees | Standard Deviation 3.3 |
| CDOA | Ankle Range of Motion | 16.0 degrees | Standard Deviation 3.4 |
| CDOB | Ankle Range of Motion | 16.3 degrees | Standard Deviation 2.8 |
| CDOC | Ankle Range of Motion | 15.5 degrees | Standard Deviation 3.6 |
Secondary
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Four Square Step Test (4SST) | 5.5 seconds | Standard Deviation 1.7 |
| CDOA | Four Square Step Test (4SST) | 6.1 seconds | Standard Deviation 1.5 |
| CDOB | Four Square Step Test (4SST) | 6.1 seconds | Standard Deviation 1.7 |
| CDOC | Four Square Step Test (4SST) | 5.8 seconds | Standard Deviation 1.5 |
Secondary
Gastrocnemius Muscle Force (N)
Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Gastrocnemius Muscle Force (N) | 1232.6 N | Standard Deviation 321.7 |
| CDOA | Gastrocnemius Muscle Force (N) | 1333.9 N | Standard Deviation 425.9 |
| CDOB | Gastrocnemius Muscle Force (N) | 1262.3 N | Standard Deviation 394.6 |
| CDOC | Gastrocnemius Muscle Force (N) | 1210.5 N | Standard Deviation 240.2 |
Secondary
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Time frame: Baseline
Population: The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Modified Socket Comfort Score (Comfort) | 6.6 score on a scale | Standard Deviation 2.2 |
| CDOA | Modified Socket Comfort Score (Comfort) | 6.8 score on a scale | Standard Deviation 1.9 |
| CDOB | Modified Socket Comfort Score (Comfort) | 8.0 score on a scale | Standard Deviation 1.9 |
Secondary
Modified Socket Comfort Score (Smoothness)
Comfort scores range from 0 = least smooth to 10 = most smooth.
Time frame: Baseline
Population: The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Modified Socket Comfort Score (Smoothness) | 6.6 score on a scale | Standard Deviation 2.1 |
| CDOA | Modified Socket Comfort Score (Smoothness) | 6.9 score on a scale | Standard Deviation 2.3 |
| CDOB | Modified Socket Comfort Score (Smoothness) | 8.3 score on a scale | Standard Deviation 1.3 |
Secondary
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Numerical Pain Rating Scale | 0.0 score on a scale | Standard Deviation 0 |
| CDOA | Numerical Pain Rating Scale | 0.0 score on a scale | Standard Deviation 0 |
| CDOB | Numerical Pain Rating Scale | 0.0 score on a scale | Standard Deviation 0 |
| CDOC | Numerical Pain Rating Scale | 0.0 score on a scale | Standard Deviation 0 |
Secondary
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| CDOA | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| CDOB | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| CDOC | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.1 |
Secondary
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Peak Ankle Power | 2.9 W/kg | Standard Deviation 0.8 |
| CDOA | Peak Ankle Power | 1.8 W/kg | Standard Deviation 0.3 |
| CDOB | Peak Ankle Power | 1.6 W/kg | Standard Deviation 0.3 |
| CDOC | Peak Ankle Power | 2.4 W/kg | Standard Deviation 0.4 |
Secondary
Plantar Force (Forefoot)
Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Plantar Force (Forefoot) | 199.0 N/kg | Standard Deviation 42.6 |
| CDOA | Plantar Force (Forefoot) | 165.7 N/kg | Standard Deviation 47.3 |
| CDOB | Plantar Force (Forefoot) | 135.2 N/kg | Standard Deviation 42 |
| CDOC | Plantar Force (Forefoot) | 149.9 N/kg | Standard Deviation 50.4 |
Secondary
Plantar Force (Hindfoot)
Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Plantar Force (Hindfoot) | 142.0 N/kg | Standard Deviation 39.5 |
| CDOA | Plantar Force (Hindfoot) | 165.9 N/kg | Standard Deviation 47.2 |
| CDOB | Plantar Force (Hindfoot) | 211.8 N/kg | Standard Deviation 75.6 |
| CDOC | Plantar Force (Hindfoot) | 184.9 N/kg | Standard Deviation 62.5 |
Secondary
Plantar Force (Midfoot)
Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Plantar Force (Midfoot) | 65.4 N/kg | Standard Deviation 19.1 |
| CDOA | Plantar Force (Midfoot) | 83.5 N/kg | Standard Deviation 21.4 |
| CDOB | Plantar Force (Midfoot) | 81.6 N/kg | Standard Deviation 33.8 |
| CDOC | Plantar Force (Midfoot) | 89.9 N/kg | Standard Deviation 32.9 |
Secondary
Plantar Force (Total Foot)
Force data (N) collected across the total foot measured between the foot and orthosis during gait.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Plantar Force (Total Foot) | 406.5 N/kg | Standard Deviation 64.7 |
| CDOA | Plantar Force (Total Foot) | 415.1 N/kg | Standard Deviation 80.5 |
| CDOB | Plantar Force (Total Foot) | 428.6 N/kg | Standard Deviation 82.2 |
| CDOC | Plantar Force (Total Foot) | 424.7 N/kg | Standard Deviation 83.3 |
Secondary
Sit to Stand 5 Times (STS5)
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Sit to Stand 5 Times (STS5) | 7.0 seconds | Standard Deviation 1.8 |
| CDOA | Sit to Stand 5 Times (STS5) | 7.7 seconds | Standard Deviation 1.7 |
| CDOB | Sit to Stand 5 Times (STS5) | 7.4 seconds | Standard Deviation 1.7 |
| CDOC | Sit to Stand 5 Times (STS5) | 7.2 seconds | Standard Deviation 1.5 |
Secondary
Soleus Muscle Force (N)
Peak Soleus muscle forces (N) will be estimated using an Opensim model
Time frame: Baseline
Population: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Soleus Muscle Force (N) | 1813.0 N | Standard Deviation 505.7 |
| CDOA | Soleus Muscle Force (N) | 1250.2 N | Standard Deviation 596.5 |
| CDOB | Soleus Muscle Force (N) | 1106.6 N | Standard Deviation 358.2 |
| CDOC | Soleus Muscle Force (N) | 1466.3 N | Standard Deviation 394.3 |
Secondary
The Orthotics Prosthetics Users' Survey (OPUS)
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0.
Time frame: Baseline
Population: The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | The Orthotics Prosthetics Users' Survey (OPUS) | 3.5 score on a scale | Standard Deviation 0.4 |
| CDOA | The Orthotics Prosthetics Users' Survey (OPUS) | 3.6 score on a scale | Standard Deviation 0.3 |
| CDOB | The Orthotics Prosthetics Users' Survey (OPUS) | 4.0 score on a scale | Standard Deviation 0.4 |
Other Pre-specified
Center of Pressure Velocity Magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Time frame: Baseline
Other Pre-specified
Center of Pressure Velocity Timing
Timing of peak center of pressure velocity (percent stance) during gait.
Time frame: Baseline
Other Pre-specified
Medial Gastrocnemius Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.
Time frame: Baseline
Other Pre-specified
Participant Device Preference
The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.
Time frame: Baseline
Other Pre-specified
Rectus Femoris Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.
Time frame: Baseline
Other Pre-specified
Semi-Structured Interview
Semi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the device options they experienced as part of the study.
Time frame: Baseline
Other Pre-specified
Soleus Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Soleus during gait.
Time frame: Baseline
Other Pre-specified
Tibialis Anterior Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait.
Time frame: Baseline
Other Pre-specified
Vastus Medialis Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.
Time frame: Baseline