Status:
ACTIVE_NOT_RECRUITING
CHAMP T 2 Pilot of CIMT by Tele-Video
Lead Sponsor:
Warren Lo
Collaborating Sponsors:
Ohio State University
Virginia Polytechnic Institute and State University
Conditions:
Hemiplegic Cerebral Palsy
Eligibility:
All Genders
4-10 years
Phase:
NA
Brief Summary
The CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the ...
Detailed Description
The CHAMP-T2 study is a pilot study of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the...
Eligibility Criteria
Inclusion
- Children who have hemiplegic cerebral palsy, ages 4-10;
- hemiparesis ranging from Manual Ability Classification System (MACS) I to MACS IV;
- 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;
- are willing to travel to these sites for two in-person assessments.
Exclusion
- Previous high dose CIMT (defined as CIMT given 2 hrs per day for 10 days) in the 6 months preceding baseline assessment;
- 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.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06486987
Start Date
June 27 2024
End Date
June 30 2027
Last Update
December 23 2025
Active Locations (2)
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1
The Ohio State University School of Health and Rehabilitation Sciences
Columbus, Ohio, United States, 43210
2
Virginia Tech-Fralin Biomedical Research Institute
Roanoke, Virginia, United States, 24016