- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156713
Constraint Induced Movement Therapy Summer Camp
February 3, 2015 updated by: Kelly Tanner
Constraint Induced Movement Therapy Summer Camp for Children With Unilateral Cerebral Palsy Ages 3-7
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
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
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
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
3 years to 7 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CIMT Camp
Members of this study will participate in the group CIMT camp.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Canadian Occupational Performance Measure Score
Time Frame: Week 5
|
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
|
|
Goal Attainment Scaling
Time Frame: Week 5
|
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
|
|
Change in Manual Ability Classification System Level
Time Frame: Week 5
|
The Manual Ability Classification System is an observation-based measure of upper extremity function in individuals with cerebral palsy.
|
Week 5
|
|
Change in Pediatric Motor Activity Log Score
Time Frame: Week 5
|
This caregiver questionnaire addresses how often and how well a child uses his or her affected extremity outside of the therapy setting.
|
Week 5
|
|
Change in Quality of Upper Extremity Skills Test Score
Time Frame: Week 5
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2014
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (ESTIMATE)
June 5, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 3, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB14-00197
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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