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

Sponsor
Teachers College, Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT00305006
Collaborator
Thrasher Research Fund (Other), Emory University (Other)
42
1
2
43.1
1

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
  • Procedure: Constraint-Induced Movement Therapy (CIMT)
  • Procedure: Hand-Arm Bimanual Intensive Therapy (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 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/.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Feb 1, 2011

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

  1. 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.

  2. 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

Ages Eligible for Study:
30 Months to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Responsible Party:
Andrew Gordon, Professor, Columbia University
ClinicalTrials.gov Identifier:
NCT00305006
Other Study ID Numbers:
  • 08126
First Posted:
Mar 21, 2006
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrew Gordon, Professor, Columbia University
Additional relevant MeSH terms:

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.
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

1. Primary Outcome
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
2. Primary Outcome
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

Both groups receive treatment.

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
Email ag275@columbia.edu
Responsible Party:
Andrew Gordon, Professor, Columbia University
ClinicalTrials.gov Identifier:
NCT00305006
Other Study ID Numbers:
  • 08126
First Posted:
Mar 21, 2006
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021