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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Transcutaneous Spinal Cord Stimulation and Gait Training

• Registration Number: NCT03384017
• Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-27
• Primary Completion: 2018-09-14
• Study Completion: 2020-10-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TSCS and gait training	Transcutaneous Spinal Cord Stimulation and Gait Training	-

Primary Outcome Measures

Name	Time	Method
Change in walking speed	at the start, week 4, and week 8	10-Meter Walk Test

Secondary Outcome Measures

Name	Time	Method
Change in walking endurance	at the start, week 4, and week 8	6-Minute Walk Test
Change in level of assistance and assistive device for walking	at the start, week 4, and week 8	Walking Index for Spinal Cord Injury II
Change in walking capacity	at the start, week 4, and week 8	Timed Up and Go

Trial Locations

Locations (1)

Rebecca Martin, OTR/L, OTD, CPAM; 🇺🇸 Baltimore, Maryland, United States