CVA, Spasticity, Muscle, Stroke
Conditions
Keywords
Dry Needling, Nervous System, Central Nervous System, Reflexes
Brief summary
The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in the muscle and relieve pain. The total study duration is 7 visits over 2 weeks. There will be 4 visits the first week, and 3 visits the second week. The first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. The second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. Dry needling will take place on the fifth visit only. During each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.
Interventions
BEHAVIORALDry Needling
Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
Sponsors
National Institute of General Medical Sciences (NIGMS)
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * no known neurological injuries. * neurologically stable for \>6 months (and \>1 yr post stroke) * medical clearance to participate * unilateral ankle and/or wrist spasticity, confirmed by Modified Ashworth Scale (MAS) \> 1 and the presence of spastic hyperreflexia
Exclusion criteria
* motoneuron injury (i.e. the neurons that give rise to the axons innervating the muscles) with inadequate response to stimulation * a cardiac condition ( history of myocardial infarction, congestive heart failure, pacemaker use, coronary artery disease, atrial fibrillation, congenital heart disease, uncontrolled hypertension) * a medically unstable condition (including temporary infections and pregnancy) * age \<18 years old * cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol * metal allergies * needle phobias * lymphedema over a limb (due to risk of infection/cellulitis) * abnormal bleeding tendencies * compromised immune system * vascular disease * uncontrolled diabetes * history of epilepsy (as DDN generates strong somatosensory sensation) * anxiety disorders or in distress * botox injection in target muscle within 3 months prior to start of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Move the Limb as Measured by Range of Motion (ROM) | Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. | ROM is measured in degrees using a standard goniometer. ROM will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves) and the value reported is the maximum degree of dorsiflexion in each condition. Positive values indicate degrees of dorsiflexion beyond neutral, negative values indicate degrees of plantarflexion. Greater values indicate greater degrees of dorsiflexion. |
| Changes in the H-reflex Amplitude in Response to Nerve Stimulation | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN | H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae. |
| Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN | Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information. |
| Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN | Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. | An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34. |
| Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDN | The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity. A score of 1.5 reported below is equal to 1+ on the mAS |
| Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN | Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain. |
| Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Timepoints are defined as baseline, 0-minutes post, 24 hours post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. | Decreased time indicates improved ability to walk |
Countries
United States
Participant flow
Pre-assignment details
Participants were enrolled in a cross-sectional study. Eleven participants were enrolled in the non-intervention week, of which 9 participants completed all visits. Those 9 participants went on to the Dry Needling Reflex Measurements, of which 8 participants completed all visits. So 11 participants were enrolled, and 8 completed the study procedures.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week.
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Dry Needling Reflex Measurment Week | Protocol Violation | 1 |
| Non-intervention Week | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Ability to Move the Limb as Measured by Range of Motion (ROM)
ROM is measured in degrees using a standard goniometer. ROM will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves) and the value reported is the maximum degree of dorsiflexion in each condition. Positive values indicate degrees of dorsiflexion beyond neutral, negative values indicate degrees of plantarflexion. Greater values indicate greater degrees of dorsiflexion.
Time frame: Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) 90-min post | 0 maximum degrees of dorsiflexion | Standard Deviation 5.26 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee flexed) post-0 min DDN | 4 maximum degrees of dorsiflexion | Standard Deviation 8.3 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) 0-min post | -26 maximum degrees of dorsiflexion | Standard Deviation 11.36 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee flexed) post-90 min DDN | 2.5 maximum degrees of dorsiflexion | Standard Deviation 6.57 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) 0-min post | 0 maximum degrees of dorsiflexion | Standard Deviation 4.62 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM post-72 hr DDN | 4.5 maximum degrees of dorsiflexion | Standard Deviation 4.64 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) 90-min post | -26.5 maximum degrees of dorsiflexion | Standard Deviation 9.34 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) baseline | -24.5 maximum degrees of dorsiflexion | Standard Deviation 13.8 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) 72 hour post | 0 maximum degrees of dorsiflexion | Standard Deviation 6.2 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) post-0 min DDN | -20 maximum degrees of dorsiflexion | Standard Deviation 8.29 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) 72-hr post | -22 maximum degrees of dorsiflexion | Standard Deviation 11.51 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) post-90 min DDN | -19 maximum degrees of dorsiflexion | Standard Deviation 6.85 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) baseline | -28.5 maximum degrees of dorsiflexion | Standard Deviation 10.92 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) post-72 hr DDN | -17 maximum degrees of dorsiflexion | Standard Deviation 10.92 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee flexed) baseline | 2.5 maximum degrees of dorsiflexion | Standard Deviation 6 |
| Single Arm | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) baseline | 0.5 maximum degrees of dorsiflexion | Standard Deviation 4.09 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) 72 hour post | 0 maximum degrees of dorsiflexion | Standard Deviation 11.51 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) baseline | 0 maximum degrees of dorsiflexion | Standard Deviation 3.89 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) 0-min post | 0.5 maximum degrees of dorsiflexion | Standard Deviation 3.83 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee extended) 90-min post | 3 maximum degrees of dorsiflexion | Standard Deviation 3.93 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) baseline | -24.5 maximum degrees of dorsiflexion | Standard Deviation 8.94 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) 0-min post | -22.5 maximum degrees of dorsiflexion | Standard Deviation 7.14 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) 90-min post | -22 maximum degrees of dorsiflexion | Standard Deviation 9.24 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee extended) 72-hr post | -21 maximum degrees of dorsiflexion | Standard Deviation 12.06 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee flexed) baseline | 5.5 maximum degrees of dorsiflexion | Standard Deviation 5.66 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee flexed) post-0 min DDN | 8 maximum degrees of dorsiflexion | Standard Deviation 3.7 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM (with knee flexed) post-90 min DDN | 8 maximum degrees of dorsiflexion | Standard Deviation 4.93 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | passive DF ROM post-72 hr DDN | 5.5 maximum degrees of dorsiflexion | Standard Deviation 5.28 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) baseline | -14 maximum degrees of dorsiflexion | Standard Deviation 12.71 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) post-0 min DDN | -16 maximum degrees of dorsiflexion | Standard Deviation 10.23 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) post-90 min DDN | -15.5 maximum degrees of dorsiflexion | Standard Deviation 9.52 |
| Dry Needling Reflex Measurements | Ability to Move the Limb as Measured by Range of Motion (ROM) | active DF ROM (with knee flexed) post-72 hr DDN | -15.5 maximum degrees of dorsiflexion | Standard Deviation 13.15 |
Primary
Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Time frame: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN
Population: Due to equipment malfunction, we could not obtain data with adequate quality for this analysis.
Primary
Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Time frame: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN
Population: Due to equipment malfunction, we could not obtain data with adequate quality for this analysis.
Primary
Changes in the H-reflex Amplitude in Response to Nerve Stimulation
H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae.
Time frame: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN
Population: Due to equipment malfunction, we could not obtain data with adequate quality for this analysis.
Secondary
Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity
An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34.
Time frame: Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score baseline | 22 score on a scale | Standard Deviation 5 |
| Single Arm | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score 0-min post | 24 score on a scale | Standard Deviation 5.01 |
| Single Arm | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score 90 min post | 22.5 score on a scale | Standard Deviation 5.68 |
| Single Arm | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score 72 hr post | 22.5 score on a scale | Standard Deviation 5.44 |
| Dry Needling Reflex Measurements | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score 72 hr post | 21 score on a scale | Standard Deviation 4.97 |
| Dry Needling Reflex Measurements | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score baseline | 20 score on a scale | Standard Deviation 5.23 |
| Dry Needling Reflex Measurements | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score 90 min post | 21 score on a scale | Standard Deviation 4.78 |
| Dry Needling Reflex Measurements | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | Median FMA-LE score 0-min post | 19.5 score on a scale | Standard Deviation 5.19 |
Secondary
Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain
Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain.
Time frame: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN
Population: No pain was reported by any participant throughout the study. All participants reported 0 pain at all time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain | 0 score on a scale | Standard Deviation 0 |
Secondary
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity. A score of 1.5 reported below is equal to 1+ on the mAS
Time frame: baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDN
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 1 | 3 score on a scale |
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 14 | 1.5 score on a scale |
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 8 | 3 score on a scale |
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 4 | 2 score on a scale |
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 2 | 3 score on a scale |
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 5 | 2 score on a scale |
| Single Arm | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 6 | 3 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 6 | 3 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 5 | 2 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 2 | 2 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 1 | 3 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 8 | 3 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 4 | 1.5 score on a scale |
| Dry Needling Reflex Measurements | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 14 | 1.5 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 5 | 2 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 1 | 3 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 2 | 2 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 4 | 1.5 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 6 | 3 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 8 | 3 score on a scale |
| Post-90 Min | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 14 | 1.5 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 4 | 2 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 6 | 3 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 2 | 2 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 14 | 1 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 8 | 3 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 1 | 3 score on a scale |
| Post-24 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 5 | 2 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 4 | 2 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 14 | 1 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 8 | 3 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 6 | 3 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 2 | 3 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 1 | 3 score on a scale |
| Post-72 Hrs | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | Participant 5 | 3 score on a scale |
Secondary
Change in Time Needed to Walk 10 Meter (10 m Walk Test)
Decreased time indicates improved ability to walk
Time frame: Timepoints are defined as baseline, 0-minutes post, 24 hours post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds 24 hours post | 8.175 seconds | Standard Deviation 1.99 |
| Single Arm | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds 72 hours post | 7.945 seconds | Standard Deviation 1.9 |
| Single Arm | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds 90 min post | 9.515 seconds | Standard Deviation 2.52 |
| Single Arm | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds at baseline | 9.525 seconds | Standard Deviation 2.61 |
| Dry Needling Reflex Measurements | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds 90 min post | 8.1 seconds | Standard Deviation 2 |
| Dry Needling Reflex Measurements | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds 24 hours post | 7.57 seconds | Standard Deviation 2.44 |
| Dry Needling Reflex Measurements | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds 72 hours post | 7.555 seconds | Standard Deviation 2.13 |
| Dry Needling Reflex Measurements | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Median 10MWT time in seconds at baseline | 7.91 seconds | Standard Deviation 2.25 |