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Clinical Trials/NCT03384017
NCT03384017
Completed
Not Applicable

The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country11 target enrollmentJanuary 5, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Enrollment
11
Locations
1
Primary Endpoint
Change in walking speed
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2017
End Date
October 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Martin, OTR/L, OTD

Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in walking speed

Time Frame: at the start, week 4, and week 8

10-Meter Walk Test

Secondary Outcomes

  • Change in level of assistance and assistive device for walking(at the start, week 4, and week 8)
  • Change in walking endurance(at the start, week 4, and week 8)
  • Change in walking capacity(at the start, week 4, and week 8)

Study Sites (1)

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