- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619853
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel
- MESHI kindergarten
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with Hemiplegia
Exclusion Criteria:
- No ability for a minimal extension movement in the wrist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-07-4624-AB-CTIL
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