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Bimanual Training in Children With Hemiplegia (HABIT)

Primary Purpose

Hemiplegia, Cerebral Palsy, Children

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HABIT

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring 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

Eligibility Criteria

18 Months - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Teachers College, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HABIT

Ongoing usual and customary rehabilitation care

Arm Description

Hand-Arm Bimanual Intensive Therapy (HABIT)

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.

Outcomes

Primary Outcome Measures

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.

Change from baseline in manual dexterity at 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

Change from baseline in range of upper extremity motion at 12 months

Change from baseline in goal achievement at 12 months

Change in caregiver ratings of activities identified as important goals by the caregiver

Full Information

NCT ID

NCT01413594

First Posted

August 8, 2011

Last Updated

April 13, 2021

Sponsor

Teachers College, Columbia University

Collaborators

Thrasher Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT01413594

Brief Title

Bimanual Training in Children With Hemiplegia

Acronym

HABIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Teachers College, Columbia University

Collaborators

Thrasher Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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/

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiplegia, Cerebral Palsy, Children

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HABIT

Arm Type

Experimental

Arm Description

Hand-Arm Bimanual Intensive Therapy (HABIT)

Arm Title

Ongoing usual and customary rehabilitation care

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

HABIT

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in quality of bimanual hand use at 12 months

Description

Changes in quality of how the two hands are used during manual activity as determined from video analysis.

Time Frame

12 months

Title

Change from baseline in manual dexterity at 12 months

Description

Change from baseline in timed performance of standardized manual activities

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change from baseline in upper extremity strength at 12 months

Time Frame

12 months

Title

Change from baseline in range of upper extremity motion at 12 months

Time Frame

12 months

Title

Change from baseline in goal achievement at 12 months

Description

Change in caregiver ratings of activities identified as important goals by the caregiver

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew M Gordon, PhD

Organizational Affiliation

Teachers College, Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Teachers College, Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

21715141

Citation

Hung YC, Casertano L, Hillman A, Gordon AM. The effect of intensive bimanual training on coordination of the hands in children with congenital hemiplegia. Res Dev Disabil. 2011 Nov-Dec;32(6):2724-31. doi: 10.1016/j.ridd.2011.05.038. Epub 2011 Jun 28.

Results Reference

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PubMed Identifier

21700924

Citation

Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.

Results Reference

background

PubMed Identifier

17979861

Citation

Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.

Results Reference

background

PubMed Identifier

17044964

Citation

Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.

Results Reference

background

PubMed Identifier

19160464

Citation

Gordon AM, Chinnan A, Gill S, Petra E, Hung YC, Charles J. Both constraint-induced movement therapy and bimanual training lead to improved performance of upper extremity function in children with hemiplegia. Dev Med Child Neurol. 2008 Dec;50(12):957-8. doi: 10.1111/j.1469-8749.2008.03166.x. No abstract available.

Results Reference

background

PubMed Identifier

19811524

Citation

Gordon AM. Two hands are better than one: bimanual skill development in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2010 Apr;52(4):315-6. doi: 10.1111/j.1469-8749.2009.03390.x. Epub 2009 Oct 7. No abstract available.

Results Reference

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Links:

URL

http://www.tc.edu/centers/cit/

Description

Center for Cerebral Palsy Research, TC, Columbia University

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Bimanual Training in Children With Hemiplegia

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