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

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ClinicalTrials.gov Identifier: NCT01895660
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
Ohio State University
University of Virginia
Information provided by (Responsible Party):
Stephanie DeLuca, Virginia Polytechnic Institute and State University

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.


Condition or disease Intervention/treatment Phase
Hemiparesis Cerebral Palsy Brain Injury Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multisite Trial of Pediatric Constraint-Induced Movement Therapy
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

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.




Primary Outcome Measures :
  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. [ Time Frame: Pretreatment; Post-Treatment, 6 and 12 months Follow up ]
    Functional measurements of arm use


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895660


Locations
United States, Virginia
Virginia Tech Carilion Research Institute
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Ohio State University
University of Virginia

Responsible Party: Stephanie DeLuca, Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT01895660     History of Changes
Other Study ID Numbers: 1RO11HD068345-01A1
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Keywords provided by Stephanie DeLuca, Virginia Polytechnic Institute and State University:
P-CIMT
Pediatric Constraint Induced Movement Therapy
Hemiparesis
Cerebral Palsy
Children

Additional relevant MeSH terms:
Brain Injuries
Cerebral Palsy
Paresis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Neurologic Manifestations
Signs and Symptoms