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Clinical Trial Summary

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.


Clinical Trial Description

Individuals with SCI will be asked to participate in this study over a four-week period. During the first 2 weeks (wash-in phase), individuals will participate in 6 aerobic and exercise training sessions as part of either an existing outpatient clinical program or by completing a personalized exercise plan. During the intervention phase (last 2 weeks), participants will be randomized to complete 6 training sessions of: 1) motor skill training combined with TSS (MST+TSS group) or 2) motor skill training combined with shamTSS (MST+shamTSS). All participants will complete 3 testing sessions: baseline testing 1 (prior the wash-in phase), testing 2 (after the completion of the wash-in phase and prior the intervention phase), and testing 3 (after the completion of the intervention phase) to assess their walking ability, balance, strength, and spasticity. During the intervention phase and to monitor within-session changes, participants will also complete a short version of walking function and balance assessments prior to and after each training session. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05429736
Study type Interventional
Source Shepherd Center, Atlanta GA
Contact Charles J Creech, DPT
Phone 678-877-9572
Email jacob.creech@shepherd.org
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date March 2026

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