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NCT01895660 · ClinicalTrials.gov registry record · Phase 2
Children With Hemiparesis Arm and Hand Movement Project (CHAMP Study)
A Phase 2 study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT01895660 is a Phase 2 study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 124 participants.
The verdict
NCT01895660, a Phase 2 study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
What is the CHAMP Study? The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is comparing the efficacy of alternative therapies for young children with unilateral spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus, OH) will be invited to enroll, and their parents will be provided all necessary paperwork along with informed consent documentation. Assignment to one of the alternative therapy conditions will be random. Participation in the study includes assessment of each child prior to treatment, close monitoring of the child's progress during treatment, and post-treatment evaluation at the end of therapy, as well as, 6 and 12 months later. Parents will have an active role in the project, both observing their child during therapy sessions and then engaging in home-based activities that allow the child to practice and extend new motor skills. There will be no charge for the therapy provided. What are the therapies being tested? In the past decade or so, a new form of therapy for children with hemiparetic cerebral palsy was developed and has shown to produce positive changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, \& Taub, 2003; DeLuca, Echols, Law, \& Ramey, 2006; Case-Smith, DeLuca, Stevenson, \& Ramey, 2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a multi-component form of therapy in which the child has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity. Traditionally, CIMT therapy dosages have been high - often lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important clinical and scien
Interventions
- BEHAVIORAL Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2013-07 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01895660
The ClinicalTrials.gov registry entry for NCT01895660 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation is the first listed.
NCT01895660 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01895660 about?
NCT01895660 is a clinical study titled "Children With Hemiparesis Arm and Hand Movement Project (CHAMP Study)". What is the CHAMP Study? The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is comparing the efficacy of alternative therapies for young children with unilateral spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility c...
What is the current status of trial NCT01895660?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2013-07. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01895660?
The interventions under investigation include: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01895660?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
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