Constraint Induced Movement Therapy Summer Camp

Cerebral Palsy Clinical Trial

Official title:

Constraint Induced Movement Therapy Summer Camp for Children With Unilateral Cerebral Palsy Ages 3-7

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156713
• Other study ID #: IRB14-00197
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: February 3, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy (CP). It is currently part of standard of care for children with unilateral CP, but is typically done one-on-one and with the child wearing a cast 24 hours a day during the duration of treatment. The purpose of this study is to assess the effects of an intensive group-based CIMT summer camp in which participants wear a removable cast on upper extremity function, occupational performance, and patient-specific goals. The investigators hypothesize that upper extremity skills and occupational performance will increase, and that patients will reach their individualized goals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Scores of level I, II or III on the Manual Ability Classification System

• Independent grasp

• Ability to ambulate independently or with an assistive device

• Sufficient cooperation and cognitive understanding to participate in a group.

Exclusion Criteria:

• Lack of hand function

• Fixed contractures

• Active seizures

• High tone

• Medical instability

• Non-English speaking parents.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Diplegic, Infantile
• Paralysis

Intervention

Behavioral:
• CIMT Camp

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kelly Tanner

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Canadian Occupational Performance Measure Score	The Canadian Occupational Performance Measure asks parents to rate their child's level of occupational performance as well as how satisfied they are with it both before and after treatment.	Week 5	No
Primary	Goal Attainment Scaling	Parents and therapists identify appropriate goals for the child to achieve at the end of therapy. The therapist then identifies "levels of attainment" for each individual goal.	Week 5	No
Primary	Change in Manual Ability Classification System Level	The Manual Ability Classification System is an observation-based measure of upper extremity function in individuals with cerebral palsy.	Week 5	No
Primary	Change in Pediatric Motor Activity Log Score	This caregiver questionnaire addresses how often and how well a child uses his or her affected extremity outside of the therapy setting.	Week 5	No
Primary	Change in Quality of Upper Extremity Skills Test Score	This is an observation-based measure during which the therapist evaluates the quality of an individual's upper extremity movement with regard to dissociated movement, grasp, protective extension, and weight bearing.	Week 5	No