Using remote ischemic conditioning to improve bimanual skills in children with unilateral cerebral palsy
Remote Ischemic Conditioning Combined With Bimanual Task Training to Enhance Bimanual Skill Learning and Corticospinal Excitability in Children With Unilateral Cerebral Palsy
This study is testing if a special treatment that uses a blood pressure cuff can help children with unilateral cerebral palsy improve their ability to use both hands together better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | East Carolina University Academic / other |
| Locations | 1 site (Greenville, North Carolina) |
| Trial ID | NCT05777070 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of remote ischemic conditioning (RIC) combined with bimanual skill training on enhancing motor learning and neuroplasticity in children with unilateral cerebral palsy (UCP). The trial involves 46 children aged 6-16 years who will undergo assessments of bimanual skill performance and corticospinal excitability before and after receiving either RIC or sham conditioning alongside training. The RIC is administered through cyclic inflation and deflation of a blood pressure cuff on the paretic arm, aiming to improve bimanual coordination and skill learning. The study is designed as a triple-blind, randomized controlled trial to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-16 years diagnosed with unilateral cerebral palsy who have manual ability classification levels I-III.
Not a fit: Patients with other developmental disabilities or significant medical conditions that affect motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance bimanual skill learning and independence in children with unilateral cerebral palsy.
How similar studies have performed: Preliminary clinical trials have shown promising results for remote ischemic conditioning in enhancing motor learning, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children diagnosed with unilateral cerebral palsy (UCP) 2. Manual Ability Classification System (MACS) levels I-III 3. Ability to complete a stack of 3 cups in 1 minute 4. Mainstream in school Exclusion Criteria: 1. Children with other developmental disabilities such as autism, attention deficit hyperactivity disorder, developmental coordination disorders, etc. 2. Children with absent active motor threshold 3. Children with known cardiorespiratory, vascular, and metabolic disorders 4. Children with neoplasm and hydrocephalus 5. Children who are currently receiving or received other adjunct therapies such as rTMS and tDCS in the past 6 months 6. Children with seizures within last 2 years and on anti-seizure medications 7. Children with metal implants and incompatible medical devices
Where this trial is running
Greenville, North Carolina
- Dept. of Physical Therapy, East Carolina University — Greenville, North Carolina, United States (Recruiting)
Study contacts
- 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.