CHAMP T 2 Pilot of CIMT by Tele-Video (NCT06486987) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CHAMP T 2 Pilot of CIMT by Tele-Video
United States10 participantsStarted 2024-06-27
Plain-language 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 pre-, post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy. The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Melbourne Assessment of Unilateral Upper Limb Function
Timeframe: At baseline pre-treatment and at the end of the 4-week intervention