Expired Study
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Roanoke, Virginia 24016


Purpose:

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 scientific questions that need to be answered about the effects of different dosage levels and about different types of constraint on the child's more functional (less impaired) arm and hand. This study will be the first that will directly compare different amounts of therapy and different types of constraint to evaluate what "works best" for young children. The therapy is very play-like and engaging for children, and no negative effects of casting or the high dosages have been detected in previous clinical trials. Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral spastic cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy, not currently receiving Botox (or other similar medications), and able to understand simple communication and instructions. In advance, the treatment will be explained in detail to parents and a written protocol available to share with the child's physician and other current therapist for review. During the one month of treatment, children will not receive other forms of physical or occupational therapy.


Criteria:

Inclusion Criteria: 1. are 2 years - 8 years old 2. do not have any serious complicating conditions or acute medical concerns 3. are diagnosed with cerebral palsy with hemiparesis (prior to age 2) 4. have not had botox injections in the last 6 months and 5. have not received Constraint-Induced Movement Therapy in the last 6 months 6. have a clinical MRI that can be provided in digital format for research project Exclusion Criteria: -


Study is Available At:


Original ID:

1RO11HD068345-01A1


NCT ID:

NCT01895660


Secondary ID:


Study Acronym:

CHAMP


Brief Title:

Children With Hemiparesis Arm and Hand Movement Project (CHAMP Study)


Official Title:

A Multisite Trial of Pediatric Constraint-Induced Movement Therapy


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

2 Years


Maximum Age:

9 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Virginia Polytechnic Institute and State University


Oversight Authority:

  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

135


Enrollment Type:

Anticipated


Study Dates

Start Date:July 2013
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:December 2018
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 11, 2019
First Received Date:June 25, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Modified version of Quality of Upper Extremity Skills Test (QUEST)
Time Frame:Pre treatment; Post-Treatment (end of 4 weeks of treatment), 6 and 12 months Follow up
Safety Issues:False
Description:Functional range of motion measure
Outcome Type:Primary Outcome
Measure:Functional measurements of change across time in the child's abilities with their arms and hands will be measured using the Assisting Hand Assessment, the Peabody Developmental Motor Scales, and the Pediatric Evaluation and Disability Inventory.
Time Frame:Pretreatment; Post-Treatment, 6 and 12 months Follow up
Safety Issues:False
Description:Functional measurements of arm use

Study Interventions

Intervention Type:Behavioral
Name:Variations in Pediatric Constraint-Induced Movemen
Description:Types of constraint and dosage amounts will be varied.
Arm Name:Group with continuous constraint and daily therapy

Study Arms

Study Arm Type:Active Comparator
Arm Name:Usual and customary treatment group
Study Arm Type:Experimental
Arm Name:Group with part-time constraint and 3 days a week therapy
Study Arm Type:Experimental
Arm Name:Group with part-time constraint and daily therapy
Study Arm Type:Experimental
Arm Name:Group with continuous constrainit and 3 days a week therapy
Study Arm Type:Experimental
Arm Name:Group with continuous constraint and daily therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Virginia Polytechnic Institute and State University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Ohio State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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