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Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

Primary Purpose

Cerebral Palsy, Hemiplegia, Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constraint-Induced Movement Therapy (CIMT)
Hand-Arm Bimanual Intensive Therapy (HABIT)
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy 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

Eligibility Criteria

30 Months - 14 Years (Child)All SexesDoes not accept 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

Experimental

Arm Label

CIMT Intervention

HABIT Intervention

Arm Description

Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.

Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.

Outcomes

Primary Outcome Measures

Change in Score on Assisting Hand Assessment (AHA)
The Assisting Hand Assessment (AHA) quantifies the effectiveness with which a child with unilateral disability uses his/her affected (assisting) hand in bimanual activity. Scores range from 0-100 units, with higher scores signifying better bimanual performance.
Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)
The Jebsen-Taylor Test of Hand Function (JTTHF) is a standardized test of simulated functional tasks quantifying the time to complete a battery of unimanual tasks. The activities performed include flipping index cards, object placement, simulated eating, stacking checkers, and manipulating empty and full cans. Scores range from 0-1080 seconds, with a lower score signifying better hand function.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2006
Last Updated
May 6, 2021
Sponsor
Teachers College, Columbia University
Collaborators
Thrasher Research Fund, Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00305006
Brief Title
Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Official Title
Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teachers College, Columbia University
Collaborators
Thrasher Research Fund, Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized control trial of bimanual training. 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.
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 1998 with constraint-induced movement therapy in children with cerebral palsy. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. We 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
Cerebral Palsy, Hemiplegia, Children, Pediatric
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIMT Intervention
Arm Type
Experimental
Arm Description
Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.
Arm Title
HABIT Intervention
Arm Type
Experimental
Arm Description
Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
Intervention Type
Procedure
Intervention Name(s)
Constraint-Induced Movement Therapy (CIMT)
Intervention Description
90 hours
Intervention Type
Procedure
Intervention Name(s)
Hand-Arm Bimanual Intensive Therapy (HABIT)
Intervention Description
90 hours
Primary Outcome Measure Information:
Title
Change in Score on Assisting Hand Assessment (AHA)
Description
The Assisting Hand Assessment (AHA) quantifies the effectiveness with which a child with unilateral disability uses his/her affected (assisting) hand in bimanual activity. Scores range from 0-100 units, with higher scores signifying better bimanual performance.
Time Frame
Baseline, 6 months
Title
Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)
Description
The Jebsen-Taylor Test of Hand Function (JTTHF) is a standardized test of simulated functional tasks quantifying the time to complete a battery of unimanual tasks. The activities performed include flipping index cards, object placement, simulated eating, stacking checkers, and manipulating empty and full cans. Scores range from 0-1080 seconds, with a lower score signifying better hand function.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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, Ph.D.
Organizational Affiliation
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
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
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PubMed Identifier
16836774
Citation
Charles JR, Wolf SL, Schneider JA, Gordon AM. Efficacy of a child-friendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2006 Aug;48(8):635-42. doi: 10.1017/S0012162206001356.
Results Reference
background
PubMed Identifier
16510616
Citation
Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.
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
18224309
Citation
Steenbergen B, Charles J, Gordon AM. Fingertip force control during bimanual object lifting in hemiplegic cerebral palsy. Exp Brain Res. 2008 Mar;186(2):191-201. doi: 10.1007/s00221-007-1223-6. Epub 2008 Jan 26.
Results Reference
background
PubMed Identifier
19087099
Citation
Schertz M, Gordon AM. Changing the model: a call for a re-examination of intervention approaches and translational research in children with developmental disabilities. Dev Med Child Neurol. 2009 Jan;51(1):6-7. doi: 10.1111/j.1469-8749.2008.03220.x. No abstract available.
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
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
background
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
result
Links:
URL
http://www.tc.edu/centers/cit/
Description
Center for cerebral palsy research

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Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

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