Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 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:
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CIMT Intervention 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. |
Procedure: Constraint-Induced Movement Therapy (CIMT)
90 hours
|
Experimental: HABIT Intervention Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually. |
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT)
90 hours
|
Outcome Measures
Primary Outcome Measures
- Change in Score on Assisting Hand Assessment (AHA) [Baseline, 6 months]
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) [Baseline, 6 months]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Teachers College, Columbia University | New York | New York | United States | 10027 |
Sponsors and Collaborators
- Teachers College, Columbia University
- Thrasher Research Fund
- Emory University
Investigators
- Principal Investigator: Andrew M Gordon, Ph.D., Columbia University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Study Results
Participant Flow
Recruitment Details | Participants were recruited from clinics in the NYC area, and online support groups from June 2007 to July 2009. Participants were firs screened via e-mail and/or telephone and potentially invited to receive an on-site physical examination or an examination videotaped by their physical occupational therapist. |
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Pre-assignment Detail |
Arm/Group Title | CIMT | HABIT |
---|---|---|
Arm/Group 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. |
Period Title: Overall Study | ||
STARTED | 22 | 22 |
COMPLETED | 21 | 21 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | CIMT | HABIT | Total |
---|---|---|---|
Arm/Group 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. | Total of all reporting groups |
Overall Participants | 21 | 21 | 42 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
6.3
(2.2)
|
6.4
(1.11)
|
6.3
(2.0)
|
Sex: Female, Male (Count of Participants) | |||
Female |
12
57.1%
|
10
47.6%
|
22
52.4%
|
Male |
9
42.9%
|
11
52.4%
|
20
47.6%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
1
4.8%
|
1
4.8%
|
2
4.8%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
3
14.3%
|
4
19%
|
7
16.7%
|
White |
15
71.4%
|
12
57.1%
|
27
64.3%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
2
9.5%
|
4
19%
|
6
14.3%
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
Subject sample size calculation based on prior data. intention to treat (ITT) was used. |
Arm/Group Title | CIMT | HABIT |
---|---|---|
Arm/Group 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. |
Measure Participants | 21 | 21 |
Mean (95% Confidence Interval) [score] |
0.42
|
0.56
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | CIMT |
---|---|---|
Comments | ANOVA | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.01 |
Comments | ANOVA | |
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1 | |
Confidence Interval |
(2-Sided) 95% to |
|
Parameter Dispersion |
Type: Standard Deviation Value: 1 |
|
Estimation Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | CIMT | HABIT |
---|---|---|
Arm/Group 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. |
Measure Participants | 21 | 21 |
Mean (90% Confidence Interval) [score] |
-141.7
|
-131.2
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | CIMT | HABIT | ||
Arm/Group 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. | ||
All Cause Mortality |
||||
CIMT | HABIT | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/21 (0%) | 0/21 (0%) | ||
Serious Adverse Events |
||||
CIMT | HABIT | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/21 (0%) | 0/21 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
CIMT | HABIT | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/21 (0%) | 0/21 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Andrew Gordon |
---|---|
Organization | Teachers College, Columbia University |
Phone | 212-678-3326 |
ag275@columbia.edu |
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