Back to resultsConstraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)
Primary Purpose
Cerebral Palsy, Hand Function
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CIMT+HABIT
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy
Eligibility Criteria
Inclusion Criteria:
- active wrist extension/dorsiflexion of at least 20;
- MACS 1-3;
- GMFCS 1-2;
- enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence.
Exclusion criteria:
- seizures;
- severely increased muscle tone; or hemi arm to good;
- orthopedic surgery on the upper extremity;
- botulin toxin injections within the past half year to the upper extremity;
- inability to understand instructions or cognitive/behavior/concentration.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CIMT+HABIT
Arm Description
Form of "summer camp", for six hours per day for 10 consecutive work days.
Outcomes
Primary Outcome Measures
Assisting Hand Assessment
Rasch built, it measures how effectively a child with unilateral disability typically makes use of their affected (assisting) hand during bimanual performance. It is conducted by a semi-structured play session requiring bimanual handling that is video-recorded. Scoring is performed by a analyzing the video on 22 predefined items using a 4-point criterion-referenced rating scale
Secondary Outcome Measures
Jebsen-Taylor Test of Hand Function
The Pediatric Evaluation of Disability Inventory (PEDI)
Muscle strength
Full Information
NCT ID
NCT01078766
First Posted
February 28, 2010
Last Updated
April 7, 2016
Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01078766
Brief Title
Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)
Official Title
Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The combination of the constraint-induced movement therapy (CIMT) method as a complement to hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand use and function in children with hemiplegic CP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hand Function
Keywords
cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CIMT+HABIT
Arm Type
Experimental
Arm Description
Form of "summer camp", for six hours per day for 10 consecutive work days.
Intervention Type
Other
Intervention Name(s)
CIMT+HABIT
Intervention Description
The daily schedule included one hour of constraining the functional arm with intensive activation of the hemi-paretic arm and then 5 hours of various structured, intensive bimanual functional activities,
Primary Outcome Measure Information:
Title
Assisting Hand Assessment
Description
Rasch built, it measures how effectively a child with unilateral disability typically makes use of their affected (assisting) hand during bimanual performance. It is conducted by a semi-structured play session requiring bimanual handling that is video-recorded. Scoring is performed by a analyzing the video on 22 predefined items using a 4-point criterion-referenced rating scale
Time Frame
twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
Secondary Outcome Measure Information:
Title
Jebsen-Taylor Test of Hand Function
Time Frame
twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
Title
The Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame
twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
Title
Muscle strength
Time Frame
twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
active wrist extension/dorsiflexion of at least 20;
MACS 1-3;
GMFCS 1-2;
enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence.
Exclusion criteria:
seizures;
severely increased muscle tone; or hemi arm to good;
orthopedic surgery on the upper extremity;
botulin toxin injections within the past half year to the upper extremity;
inability to understand instructions or cognitive/behavior/concentration.
12. IPD Sharing Statement
Learn more about this trial
Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)
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