Bimanual Training in Children With Hemiplegia

Study Overview
=================
Brief Summary
-----------------
A randomized control trial of bimanual training in children with hemiplegia. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators will test the hypothesis that bimanual training (HABIT) will result in improved hand function in children with hemiplegia.

Detailed Description
-----------------
A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators developed HABIT in 2004 as an alternative to constraint-therapy that avoids use of a restraint. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. The investigators have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Official Title
-----------------
Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)

Conditions
-----------------
Hemiplegia, Cerebral Palsy, Children

Intervention / Treatment
-----------------
* Behavioral: HABIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: *willingness to agree to intervention and testing procedures and travel to the University for participation and testing Exclusion Criteria: health problems not associated with CP uncontrollable seizures visual problems that would interfere with carrying out the intervention or testing botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HABIT<br>Hand-Arm Bimanual Intensive Therapy (HABIT) | Behavioral: HABIT<br>* 90 hours of bimanual training over 3 weeks in a day camp environment<br>* Other names: constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy;|
| No Intervention: Ongoing usual and customary rehabilitation care<br>Subjects are tested over 6 months while receiving their ongoing usual and customary care schedule of physical and occupational therapy or following constraint-induced movement therapy received as usual and customary care independent of the study, and then are crossed-over to receive HABIT. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in quality of bimanual hand use at 12 months | Changes in quality of how the two hands are used during manual activity as determined from video analysis. | 12 months | 
| Change from baseline in manual dexterity at 12 months | Change from baseline in timed performance of standardized manual activities | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in upper extremity strength at 12 months |  | 12 months | 
| Change from baseline in range of upper extremity motion at 12 months |  | 12 months | 
| Change from baseline in goal achievement at 12 months | Change in caregiver ratings of activities identified as important goals by the caregiver | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, constraint-induced therapy, constraint-induced movement therapy, CP, hemiplegia, hand, forced use, motor control, children, HABIT, Hand-arm bimanual intensive therapy, bilateral training, bimanual training, functional therapy, physical therapy, occupational therapy, intensive, pediatric, development, upper extremity, hemiplegic, childhood stroke