Remote blood-flow conditioning plus balance training for children with cerebral palsy
Effects of Remote Ischemic Conditioning (RIC) Combined With Balance Training on Spinal Reflex Modulation in Children With Cerebral Palsy
This study will test whether brief, safe cycles of limb blood-flow restriction combined with balance training can change spinal reflexes and improve balance in children with cerebral palsy aged 8–17.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | East Carolina University Academic / other |
| Locations | 1 site (Greenville, North Carolina) |
| Trial ID | NCT07390760 on ClinicalTrials.gov |
What this trial studies
This interventional study will enroll 16 children with cerebral palsy (ages 8–17, GMFCS I–III) to receive either remote ischemic conditioning (brief, non-invasive cycles of cuff occlusion and reperfusion) or sham conditioning, each paired with balance training. Spinal reflex excitability will be measured using H-reflex recordings before and after the intervention, and standardized balance performance tests will track functional change. The protocol compares physiological (H-reflex) and clinical balance outcomes between the RIC and sham groups to see if RIC enhances training-related neuroplasticity at the spinal level. Participants will attend visits at the study site in Greenville, North Carolina for conditioning, training, and outcome testing.
Who should consider this trial
Good fit: Ideal candidates are children with cerebral palsy aged 8–17 years who are GMFCS levels I–III, attend mainstream school, can follow instructions, and do not have excluded medical or developmental conditions.
Not a fit: Children with significant cognitive or communication impairments, other developmental disabilities (like autism), vestibular or other balance disorders, cardiorespiratory disease, sickle cell disease, recent lower-extremity injury/surgery, or who are receiving other neuromodulation therapies are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, combining remote ischemic conditioning with balance training could reduce abnormal spinal reflex excitability and lead to better balance and functional mobility for some children with cerebral palsy.
How similar studies have performed: Prior work in healthy adults and some neurological populations has shown motor and balance gains when RIC is combined with training, but effects specifically on spinal reflex modulation in children with cerebral palsy are largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children diagnosed with cerebral palsy (CP) between the ages 8-17 years * Gross motor function classification system levels I-III * Mainstream in school and has sufficient cognition to follow the experiment instructions Exclusion Criteria: * Children with other developmental disabilities such as autism and developmental coordination disorders * Children with cognitive deficits such as inability to understand and follow commands, substantially lower performance at grade level in school, and/or communication problems * Children with balance disorders such as vestibular disorders, posterior fossa tumor etc. * Children with known cardiorespiratory dysfunctions * Children with sickle cell disease * Children who are receiving other adjunct therapies such as transcranial magnetic stimulation, transcranial direct current stimulation, or vagal nerve stimulation * Presence of lower extremity condition, injury, or surgery within last three months which could compromise conditioning and training. * Participants who are pregnant.
Where this trial is running
Greenville, North Carolina
- East Carolina University — Greenville, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Swati M Surkar, PhD — East Carolina University
- Study coordinator: Swati M Surkar, PhD
- Email: surkars19@ecu.edu
- Phone: 2527446244
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.