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

March 10, 2022 updated by: Stephanie DeLuca, Virginia Polytechnic Institute and State University

A Multisite Trial of Pediatric Constraint-Induced Movement Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at Virginia Tech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group with continuous constraint and daily therapy
Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Types of constraint and dosage amounts will be varied.
EXPERIMENTAL: Group with continuous constrainit and 3 days a week therapy
Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Types of constraint and dosage amounts will be varied.
EXPERIMENTAL: Group with part-time constraint and daily therapy
Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Types of constraint and dosage amounts will be varied.
EXPERIMENTAL: Group with part-time constraint and 3 days a week therapy
Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Types of constraint and dosage amounts will be varied.
ACTIVE_COMPARATOR: Usual and customary treatment group
Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Types of constraint and dosage amounts will be varied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Functional measurements of arm use
Pretreatment; Post-Treatment, 6 and 12 months Follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Functional range of motion measure
Pre treatment; Post-Treatment (end of 4 weeks of treatment), 6 and 12 months Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

Ohio State University
University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (ESTIMATE)

July 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1RO11HD068345-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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