The Influence of MCIMT (Modified Constrained Induced Movement Therapy), Bilateral Intensive Treatment, and NDT Approach on the UL Function in Children With Hemiplegic Cerebral Palsy (CIMT)
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
treatment approach - CIMT
treatment approach - HABIT
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Improving the assisting hand function in children with Hemiplegic Cerebral palsy
Eligibility Criteria
Inclusion Criteria:
- Children with Hemiplegia
Exclusion Criteria:
- No ability for a minimal extension movement in the wrist
Sites / Locations
- MESHI kindergarten
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00619853
First Posted
February 10, 2008
Last Updated
February 20, 2008
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00619853
Brief Title
The Influence of MCIMT (Modified Constrained Induced Movement Therapy), Bilateral Intensive Treatment, and NDT Approach on the UL Function in Children With Hemiplegic Cerebral Palsy
Acronym
CIMT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study was to compare unimanual training (CIMT) and bimanual training (HABIT) protocols aimed to improve ability of the involved hand in children with hemiplegia. Both protocols were conducted in an educational setting for 2 hours a day for 2 months, one-hour group session and one-hour individual therapy session conducted by occupational therapists or assistants.
The children in the CIMT group practiced various tasks using their involved hand with the contralateral hand constrained with a mitt. The children at the HABIT group practiced various bimanual tasks without constraint.
Twelve children (2 - 6.5 yrs.) participated in this study. The inclusion criterion included minimal extension movement of the involved wrist, and for the CIMT group, the ability to of tolerates the mitt. The children were matched in relation to cognitive level and MACS score and randomly divided into the two intervention groups.
Each child's assessment included the Quality of Upper Extremity Skills Test (QUEST), the Assisting Hand Assessment (AHA), and the Blocks and Box for children above age 5 yrs old. Range of motion (ROM) was assessed using an electronic gonimeter, and muscle tone was recorded using surface EMG and the Tardiue scale. The Child Health Questioner (CHQ) was completed by the parents before, and 6 months after, the intervention. Children were assessed starting two month before, and two month after, the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Improving the assisting hand function in children with Hemiplegic Cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
treatment approach - CIMT
Intervention Description
CIMT, 2 months, 2Hr per day
Intervention Type
Behavioral
Intervention Name(s)
treatment approach - HABIT
Intervention Description
HABIT-2 months, 2Hr per day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with Hemiplegia
Exclusion Criteria:
No ability for a minimal extension movement in the wrist
Facility Information:
Facility Name
MESHI kindergarten
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Influence of MCIMT (Modified Constrained Induced Movement Therapy), Bilateral Intensive Treatment, and NDT Approach on the UL Function in Children With Hemiplegic Cerebral Palsy
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