Upper extremity orthotic device for children with cerebral palsy
Use of Low Cost Orthotic Device to Improve Upper Extremity Function in Children With Cerebral Palsy
This study is testing a new splint for children with cerebral palsy to see if it can help them use their hands better while they also receive therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Newark, New Jersey and 1 other locations) |
| Trial ID | NCT05024409 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a dynamic splint, or exoskeleton, designed to improve upper extremity function in children with cerebral palsy who have limited hand use. The device aims to utilize the tenodesis effect from elbow motion to facilitate finger release while maintaining flexor tone for grasping. Targeting children aged 4-17 with moderate to severe hand disabilities, the study will assess how this orthotic device, combined with occupational therapy, can enhance functional abilities. The focus is on those classified as MACS III-V, who currently lack evidence-based interventions tailored to their needs.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-17 with a diagnosis of cerebral palsy and moderate to severe hand disabilities.
Not a fit: Patients with mild or extremely severe hand disabilities, or those unable to follow commands due to severe cognitive impairment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve hand function and overall quality of life for children with cerebral palsy.
How similar studies have performed: While there is limited evidence for similar approaches specifically targeting this population, the concept of using orthotic devices for improving function in children with disabilities has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of cerebral palsy, age 4-17 years, moderate-severe hand disability as graded by the Manual Ability Classification System, active movement of the elbow, ability to follow commands and participate in goal-making and repetitive tasks Exclusion Criteria: * mild or extremely severe hand disability, Botox or orthopaedic surgery within the past 6 months, severe contractures, lack of voluntary arm motion, unable to follow commands due to severe cognitive impairment
Where this trial is running
Newark, New Jersey and 1 other locations
- Rutgers NJMS — Newark, New Jersey, United States (Recruiting)
- Children's Specialized Hospital — Union, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Alice Chu, MD
- Email: chual@njms.rutgers.edu
- Phone: 973 972 2076
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.