Tele-video therapy for children with hemiplegic cerebral palsy
Efficacy of Constraint Induced Movement Therapy Delivered by Tele-Video for Children With Hemiplegic Cerebral Palsy
This study is testing if doing constraint induced movement therapy through video calls can help improve the arm function of children with hemiplegic cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 5 Years to 10 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 2 sites (Columbus, Ohio and 1 other locations) |
| Trial ID | NCT06486987 on ClinicalTrials.gov |
What this trial studies
The CHAMP-T2 study evaluates the effectiveness of constraint induced movement therapy (CIMT) delivered via tele-video in the homes of children with hemiplegic cerebral palsy. This pilot study focuses on assessing the motor function of the affected limb before and after a 4-week intervention. The primary outcome is the change in upper extremity function, measured by the Melbourne Assessment of Unilateral Upper Limb Function, while secondary outcomes include bilateral function and parental observations. The results will help design a larger study comparing tele-delivered CIMT with standard care.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-10 with hemiplegic cerebral palsy and hemiparesis classified as MACS II to MACS IV.
Not a fit: Patients who have previously undergone high dose CIMT or have certain medical or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve upper limb function in children with hemiplegic cerebral palsy, enhancing their quality of life.
How similar studies have performed: While tele-delivered therapies are gaining traction, this specific approach to CIMT via tele-video is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children who have hemiplegic cerebral palsy, ages 5-10; who have hemiparesis ranging from Manual Ability Classification System (MACS) II to MACS IV, and live within a 1.5 hour distance from therapists' worksites at the Ohio State University Wexner Medical Center in Columbus, Ohio, or the Fralin Biomedical Research Institute in Roanoke, Virginia Exclusion Criteria: * Previous high dose CIMT (defined as CIMT given 2 hrs per day for 10 days); Treatment with botulinum toxin for spasticity in the 3 months preceding baseline assessment; Surgery for spasticity in the 6 months preceding baseline assessment; Medically unstable and unable to participate in the treatment intervention; Child is behaviorally or cognitively impaired so unable to participate in the treatment intervention; Family unable to participate in tele-delivery of CIMT 5 days a week for 4 weeks; the caregiver available at child's treatment site during treatment times is unable to communicate with the treating therapist.
Where this trial is running
Columbus, Ohio and 1 other locations
- The Ohio State University School of Health and Rehabilitation Sciences — Columbus, Ohio, United States (Recruiting)
- Virginia Tech-Fralin Biomedical Research Institute — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Warren Lo, MD — Nationwide Children's Hospital
- Study coordinator: Petra Sternberg, PhD, CCRP
- Email: Petra.Sternberg@osumc.edu
- Phone: 614-572-5446
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.