Brief 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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

124

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2013

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

First Submitted

Initial submission to the registry

June 25, 2013

Completed

6 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed

9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed

Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

5.4 years

First QC Date

June 25, 2013

Last Update Submit

March 10, 2022

Conditions

Hemiparesis Cerebral Palsy Brain Injury

Keywords

P-CIMTPediatric Constraint Induced Movement TherapyHemiparesisCerebral PalsyChildren

Outcome Measures

Primary Outcomes (1)

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.
Functional measurements of arm use
Pretreatment; Post-Treatment, 6 and 12 months Follow up

Secondary Outcomes (1)

Modified version of Quality of Upper Extremity Skills Test (QUEST)
Pre treatment; Post-Treatment (end of 4 weeks of treatment), 6 and 12 months Follow up