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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00619853
First received: February 10, 2008
Last updated: February 20, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hemiplegic Cerebral Palsy
Behavioral: treatment approach - CIMT
Behavioral: treatment approach - HABIT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Study Start Date: June 2007
Estimated Study Completion Date: October 2007
Intervention Details:
    Behavioral: treatment approach - CIMT
    CIMT, 2 months, 2Hr per day
    Behavioral: treatment approach - HABIT
    HABIT-2 months, 2Hr per day
  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with Hemiplegia

Exclusion Criteria:

  • No ability for a minimal extension movement in the wrist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619853

Locations
Israel
MESHI kindergarten
Jerusalem, Israel
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00619853     History of Changes
Other Study ID Numbers: SHEBA-07-4624-AB-CTIL
Study First Received: February 10, 2008
Last Updated: February 20, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Improving the assisting hand function in children with Hemiplegic Cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014