HABIT: Bimanual Training in Children With Hemiplegia

Sponsor

Teachers College, Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT01413594

Collaborator

Thrasher Research Fund (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia Cerebral Palsy Children	Behavioral: HABIT	N/A

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/

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HABIT Hand-Arm Bimanual Intensive Therapy (HABIT)	Behavioral: HABIT 90 hours of bimanual training over 3 weeks in a day camp environment Other Names: constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy
No Intervention: Ongoing usual and customary rehabilitation care 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.

Arm

Intervention/Treatment

Experimental: HABIT

Hand-Arm Bimanual Intensive Therapy (HABIT)

Behavioral: HABIT

90 hours of bimanual training over 3 weeks in a day camp environment

Other Names:

constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy

No Intervention: Ongoing usual and customary rehabilitation care

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in quality of bimanual hand use at 12 months [12 months]
Changes in quality of how the two hands are used during manual activity as determined from video analysis.
Change from baseline in manual dexterity at 12 months [12 months]
Change from baseline in timed performance of standardized manual activities

Secondary Outcome Measures

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 [12 months]
Change in caregiver ratings of activities identified as important goals by the caregiver

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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