Clinical Trial

Epidural Stimulation and Resistance Training After SCI

Study acronym: REST-SCI
Recruiting Phase 2/3
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Record status
This record was last updated January 2, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-03-02; most recent amendment 2025-12-31.
Status change: Withheld → Recruiting 2022-02-02
Trial Details
NCT Number NCT04782947
Lead Sponsor United States Department of Defense
Collaborators: Central Virginia VA Health Care System
Conditions Spinal Cord Injuries
Enrollment 20 participants
Start Date 2021-02-03
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-02