Active — Not RecruitingNot Applicable

Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

United States28 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be 18-70 years of age * Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment * Have ISNCSCI severity classification C or D * Able to stand for at least 5 minutes (with or without the aid of an assistive device) * Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device) * Able to rise from sit to stand with moderate assistance from one person * Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation * Ability and willingness to consent and authorize use of personal health information * Ability to follow multiple instructions and communicate pain or discomfort Exclusion Criteria: * Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord * Injuries below the neurological spinal level of T12 * Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS * History of cardiovascular irregularities * Presence of orthopedic conditions that would adversely affect participation in exercise * Implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g., baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, d…

What they're measuring

Change in 10 Meter Walk Test

Timeframe: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)

Trial details

NCT IDNCT05429736

SponsorShepherd Center, Atlanta GA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07