NCT00619853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

First QC Date

February 10, 2008

Last Update Submit

February 20, 2008

Conditions

Keywords

Improving the assisting hand function in children with Hemiplegic Cerebral palsy

Interventions

CIMT, 2 months, 2Hr per day

HABIT-2 months, 2Hr per day

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children with Hemiplegia

You may not qualify if:

  • No ability for a minimal extension movement in the wrist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MESHI kindergarten

Jerusalem, Israel

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 10, 2008

First Posted

February 21, 2008

Study Start

June 1, 2007

Study Completion

October 1, 2007

Last Updated

February 21, 2008

Record last verified: 2008-02

Locations