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Behavioural Intervention
Tele-Video CIMT for Cerebral Palsy
N/A
Recruiting
Led By Warren Lo, MD
Research Sponsored by Warren Lo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children who have hemiplegic cerebral palsy, ages 5-10, with 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
Be younger than 18 years old
Must not have
Previous high dose CIMT (defined as CIMT given 2 hrs per day for 10 days)
Medically unstable and unable to participate in the treatment intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 4 weeks of intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a therapy called constraint induced movement therapy (CIMT) for children with hemiplegic cerebral palsy. The therapy will be delivered through tele-video in the child's home
Who is the study for?
This trial is for children with hemiplegic cerebral palsy, which affects one side of their body. They should be able to participate in therapy sessions via tele-video from home or a similar setting. Specific inclusion and exclusion criteria details are not provided.
What is being tested?
The CHAMP T2 study is testing the effectiveness of constraint induced movement therapy (CIMT) delivered through tele-video to improve the use of a limb affected by cerebral palsy.
What are the potential side effects?
Since this trial involves physical therapy and not medication, traditional drug side effects are not expected. However, there may be fatigue or discomfort associated with the exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 5-10, has hemiplegic cerebral palsy with some hand use limitations and lives close to the specified locations.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have undergone intensive therapy for 2 hours daily over 10 days.
Select...
I am too ill to undergo the treatment.
Select...
My child cannot participate in the treatment due to behavioral or cognitive issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during 4 weeks of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 4 weeks of intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Melbourne Assessment of Unilateral Upper Limb Function
Secondary study objectives
Assisting Hand Assessment
Fidelity to treatment protocol
Pediatric Motor Activity Log
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
This is a single arm in an open label pre- post-treatment design to estimate effect size of the intervention
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityOTHER
156 Previous Clinical Trials
25,735 Total Patients Enrolled
4 Trials studying Cerebral Palsy
694 Patients Enrolled for Cerebral Palsy
Ohio State UniversityOTHER
871 Previous Clinical Trials
655,722 Total Patients Enrolled
7 Trials studying Cerebral Palsy
372 Patients Enrolled for Cerebral Palsy
Warren LoLead Sponsor
Warren Lo, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled