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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive Spinal Stimulation with Gait Training | Experimental | May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
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| Conventional Gait Training | Active Comparator | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive spinal stimulation with gait training | Device | Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Step-length Symmetry Using Symmetry Index | Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome. | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
| Change in Swing-time Symmetry | Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome. | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10 Meter Walk Test - Self-selected Velocity | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). |
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Healthy Control Group Inclusion Criteria:
Healthy Control Group Exclusion Criteria:
Stroke Group Inclusion Criteria:
Stroke Group Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Jayaraman, PT, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38561821 | Derived | Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Noninvasive Spinal Stimulation With Gait Training | May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Noninvasive spinal stimulation with gait training: Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities. |
| FG001 | Conventional Gait Training | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Conventional gait training: May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Noninvasive Spinal Stimulation With Gait Training | May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Noninvasive spinal stimulation with gait training: Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Step-length Symmetry Using Symmetry Index | Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome. | Posted | Mean | Standard Deviation | Symmetry Index | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
|
Adverse events were monitored/assessed throughout entirety of the study until study completion (3 months after completion of intervention)
No adverse events occurred throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Noninvasive Spinal Stimulation With Gait Training | May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Noninvasive spinal stimulation with gait training: Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities. |
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Limitations include a small sample size, between subject variability in tSCS stimulation, stim group participants were not matched to their controls based on gait symmetry (primary outcome measure)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes | Shirley Ryan AbilityLab | 3122386875 | ajayaraman@sralab.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2019 | Oct 3, 2025 | Prot_005.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2019 | Oct 3, 2025 | SAP_006.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional gait training | Device | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
|
| Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
| Change in 10 Meter Walk Test - Fast Velocity | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
| Change in 6 Minute Walk Test | The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
| Change in PCI During 6 Minute Walk Test | Participants completed the 6MWT as heart rate was recorded throughout the testing using a Polar H7 chest belt monitor. Prior to beginning the 6MWT, average resting heart rate was recorded for two minutes while the subject was seated and quiet. Cardiac efficiency during 6MWT was measured by physiological cost index (PCI), which reflects heart rate per meter walked. Reduced PCI indicates improved cardiac efficiency. | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
| BG001 | Conventional Gait Training | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Conventional gait training: May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Functional Ambulation Category (FAC) | Functional Ambulation Category is a walking test that evaluates ambulation ability, determining how much human support they requires. Higher scores represent better walking ability, with a range of 0-5. 0) Patient cannot walk, or needs help from 2 or more persons, 1) Patients needs firm continuous support from 1 person 2) Patient needs continuous or intermittent support of one person to help with balance/coordination, 3) Patient requires verbal supervision or stand-by help from 1 person, 4) Patient can walk independently on level ground 5) Patient can walk independently | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Conventional Gait Training | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Conventional gait training: May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
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| Primary | Change in Swing-time Symmetry | Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome. | Posted | Mean | Standard Deviation | Symmetry index | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
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| Secondary | Change in 10 Meter Walk Test - Self-selected Velocity | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). | Posted | Mean | Standard Deviation | meters per second | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
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| Secondary | Change in 10 Meter Walk Test - Fast Velocity | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). | Posted | Mean | Standard Deviation | meters per second | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
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| Secondary | Change in 6 Minute Walk Test | The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. | Posted | Mean | Standard Deviation | Meters | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
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| Secondary | Change in PCI During 6 Minute Walk Test | Participants completed the 6MWT as heart rate was recorded throughout the testing using a Polar H7 chest belt monitor. Prior to beginning the 6MWT, average resting heart rate was recorded for two minutes while the subject was seated and quiet. Cardiac efficiency during 6MWT was measured by physiological cost index (PCI), which reflects heart rate per meter walked. Reduced PCI indicates improved cardiac efficiency. | Posted | Mean | Standard Deviation | Beats per min | Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total) |
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| EG001 | Conventional Gait Training | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Conventional gait training: May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |