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

Hemiplegic Cerebral Palsy Clinical Trial

— CIMT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619853
• Other study ID #: SHEBA-07-4624-AB-CTIL
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2008
• Last updated: February 20, 2008
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

• Children with Hemiplegia

Exclusion Criteria:

• No ability for a minimal extension movement in the wrist

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Behavioral:
• treatment approach - CIMT
CIMT, 2 months, 2Hr per day
• treatment approach - HABIT
HABIT-2 months, 2Hr per day

Locations

Country	Name	City	State
Israel	MESHI kindergarten	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,