The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury (TSCS)
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|ClinicalTrials.gov Identifier: NCT03384017|
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions.
Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: Transcutaneous Spinal Cord Stimulation and Gait Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||All assessors will be blind to intervention|
|Official Title:||The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury|
|Actual Study Start Date :||January 5, 2017|
|Estimated Primary Completion Date :||January 5, 2019|
|Estimated Study Completion Date :||December 1, 2019|
|Experimental: TSCS and gait training||
Other: Transcutaneous Spinal Cord Stimulation and Gait Training
TSCS will be applied using a midline electrode placed on the skin between spinous process T11 -T12 and two electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50 Hz and 1 millisecond, is used to provide 30 continuous minutes of stimulation.
Subjects will participate in 24 two-hour sessions of physical therapy over eight weeks. In each session, subjects will receive TSCS continuously for 30 minutes, using the parameters outlined above. During stimulation, subjects will participate in strengthening, segmental task practice, and gait-based interventions. Participation in gait training will continue following the stimulation period for the duration of the session.
- Change in walking speed [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]10-Meter Walk Test
- Change in walking capacity [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]Timed Up and Go
- Change in level of assistance and assistive device for walking [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]Walking Index for Spinal Cord Injury II
- Change in walking endurance [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]6-Minute Walk Test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384017
|Contact: Shannon M Inchesfirstname.lastname@example.org|
|Contact: Rebecca Martin, OTR/L, OTD, CPAM||443-923-7972||MartinRe@kennedykrieger.org|
|United States, Maryland|
|Rebecca Martin, OTR/L, OTD, CPAM||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Shannon M Inches 443-923-9235 email@example.com|