Remote Ischemic Conditioning and Spinal Reflex Modulation in Children With Cerebral Palsy
Part of paid clinical trials in Greenville, North Carolina.
- Sponsor
- East Carolina University
- Study ID
- NCT07390760
- Status
- Recruiting
Conditions
- Children With Cerebral Palsy
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Remote Ischemic Condtioning (RIC) — BEHAVIORALSee descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the baseline assessment and training visit, and visits 2-4 are RIC plus training visits, Visit 5 is training and post assessment visit.
- Sham conditioning — BEHAVIORALSee descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, visits 2-5 are training visits, and visit 5 is training and post assessment visit.
- Balance training — BEHAVIORALAll participants will undergo training on a balance board, learning to hold the board level within the 5- degree horizontal range. Participants perform the balance task for 15, 30-second trials per day at visits 1-5.
Study Details
Remote ischemic conditioning (RIC) is a clinically feasible intervention involving brief, sublethal periods of ischemia followed by reperfusion that has been shown to enhance motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Although RIC is thought to influence neuroplasticity through neural, metabolic, and humoral pathways, its effects on spinal-level mechanisms remain poorly understood. Emerging evidence indicates that neuroplastic adaptations occur not only at the cortical level but also within the spinal cord. Moreover, altered spinal reflex excitability is associated with spasticity, balance impairments, and functional limitations in children with cerebral palsy (CP), yet the role of spinal reflex modulations in response to RIC and balance training remains under expplored in this population. Therefore, this study aims to investigate the effects of RIC combined with balance training on spinal reflex modulation in children with CP.
Key Dates
- Start date
- Jul 28, 2025
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Remote Ischemic Conditioning (RIC)RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the thigh of more affected lower extremity. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 1 - 5.
- Sham Comparator: Sham conditioningSham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the more affected LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-5.
Primary Outcome Measure
Change in maximal H-reflex amplitude (Hmax) [ Time Frame: [Time Frame: Baseline, Day 5] ]
Central Contacts
- Swati M Surkar, PhD2527446244
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| East Carolina University | Greenville | North Carolina | 27834 |