Using remote ischemic conditioning to improve bimanual skills in children with unilateral cerebral palsy
Effects of Remote Ischemic Conditioning on Bimanual Skill Learning, Bimanual Coordination, and Corticospinal Excitability in Children With Unilateral Cerebral Palsy
NA · East Carolina University · NCT05355883
This study is testing whether a special treatment using a blood pressure cuff can help children with unilateral cerebral palsy improve their ability to use both hands together.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | East Carolina University (other) |
| Locations | 1 site (Greenville, North Carolina) |
| Trial ID | NCT05355883 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of remote ischemic conditioning (RIC) combined with intensive bimanual skill training on children with unilateral cerebral palsy (UCP). The approach involves applying brief episodes of ischemia and reperfusion through a blood pressure cuff on the arm or leg to enhance motor learning and neuroplasticity. A total of 30 children aged 6-16 years with UCP will participate in a triple-blind, randomized controlled trial, undergoing assessments and training over five days. The study aims to evaluate improvements in bimanual skill performance and corticospinal excitability.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-16 years diagnosed with unilateral cerebral palsy who can perform basic motor tasks.
Not a fit: Patients with other developmental disabilities, cognitive deficits, or those receiving concurrent therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance bimanual coordination and independence in children with unilateral cerebral palsy.
How similar studies have performed: Preliminary clinical trials have shown neuroprotective effects of remote ischemic conditioning, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Children diagnosed with unilateral cerebral palsy, ages 6-16 years * Manual Ability Classification System (MACS) levels I-III * Ability to complete a stack of 3 cups in 2 minutes * Mainstream in school and has sufficient cognition to follow the experiment instructions Exclusion Criteria: * Children with other developmental disabilities such as autism, developmental coordination disorders, etc. * Children with absent active motor threshold * Children with cognitive deficits or communication problem * Children with known cardiorespiratory and vascular dysfunctions * Children with metabolic disorders, neoplasm, hydrocephalus * Children who are receiving other adjunct therapies such as rTMS and tDCS * Children with seizures and on anti-seizure medications * Children with metal implants and incompatible medical devices for MRI scans
Where this trial is running
Greenville, North Carolina
- Dept. of Physical Therapy, East Carolina University — Greenville, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Swati Surkar — East Carolina University
- Study coordinator: Swati Surkar, PT, 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.
Conditions: Unilateral Cerebral Palsy, Hemiplegic Cerebral Palsy, Remote Ischemic Conditioning, Cerebral palsy, Bimanual coordination, Corticospinal excitability