Improving walking and balance in people with spinal cord injuries
SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
This study is trying to see if a new training program that combines exercise with spinal stimulation can help people with spinal cord injuries walk better and improve their balance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shepherd Center, Atlanta GA Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05429736 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance walking-related outcomes for individuals with spinal cord injuries (SCI) through a combination of motor skill training (MST) and non-invasive transcutaneous spinal stimulation (TSS). Participants will undergo a four-week program consisting of aerobic and exercise training, followed by randomized sessions of MST with either TSS or sham TSS. The study will assess improvements in walking ability, balance, strength, and spasticity through multiple testing sessions. The goal is to develop a training approach that can be easily performed at home, making rehabilitation more accessible.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a spinal cord injury classified as C or D, who can stand and move their legs independently.
Not a fit: Patients with progressive spinal lesions or those unable to meet the physical requirements of the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using non-invasive spinal stimulation combined with rehabilitation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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, diaphragmatic pacemaker) * Any cuts or sensitivity of the skin near the level of stimulation * Active cancer or history of cancer * Inability and unwillingness to consent and authorize use of personal health information
Where this trial is running
Atlanta, Georgia
- Shepherd Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Edelle C Field-Fote, PT, PhD — Shepherd Center, Atlanta GA
- Study coordinator: Charles J Creech, DPT
- Email: jacob.creech@shepherd.org
- Phone: 678-877-9572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.