Status:
RECRUITING
Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
Lead Sponsor:
Shepherd Center, Atlanta GA
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Incomplete Spinal Cord Injury
Spasticity, Muscle
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 involv...
Detailed 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 sessi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05429736
Start Date
March 1 2022
End Date
March 1 2026
Last Update
September 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shepherd Center
Atlanta, Georgia, United States, 30309