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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
Sponsor:
Information provided by (Responsible Party):
Rebecca Martin, OTR/L, OTD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

December 12, 2017
December 27, 2017
December 27, 2017
January 5, 2017
January 5, 2019   (Final data collection date for primary outcome measure)
Change in walking speed [ Time Frame: At the beginning, midpoint, and end of study (study is 8 weeks) ]
10-Meter Walk Test
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury

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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
All assessors will be blind to intervention
Primary Purpose: Treatment
Spinal Cord Injuries
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.

Experimental: TSCS and gait training
Intervention: Other: Transcutaneous Spinal Cord Stimulation and Gait Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Same as current
December 1, 2019
January 5, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years old
  • >1 year post SCI
  • Non-progressive SCI
  • Neurological level above T10
  • Tolerates upright position for >30 minutes
  • Medically stable (no hospitalizations in last 3 months)
  • Able to comply with procedures and follow up
  • Are legally able to make their own health care decisions

Exclusion Criteria:

  • Progressive SCI/D (MS, ALS, ADEM, etc.)
  • Open wounds at stimulation site
  • Pregnant women
  • ROM limitations impacting gait training
  • Cardiac pacemaker/defibrillator
  • Active cancer diagnosis
  • Currently receiving TSCS
  • Evidence of uncontrolled autonomic dysreflexia
  • Non-English speaking subjects will not be targeted
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Shannon M Inches 443-923-9235 inches@kennedykrieger.org
Contact: Rebecca Martin, OTR/L, OTD, CPAM 443-923-7972 MartinRe@kennedykrieger.org
United States
 
 
NCT03384017
IRB00053916
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Rebecca Martin, OTR/L, OTD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Not Provided
Not Provided
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP