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

May 6, 2021 updated by: Andrew Gordon, Teachers College, Columbia University

Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Teachers College, Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Score on Assisting Hand Assessment (AHA)
Time Frame: 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.
Baseline, 6 months
Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)
Time Frame: 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.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teachers College, Columbia University

Collaborators

Emory University
Thrasher Research Fund

Investigators

  • Principal Investigator: Andrew M Gordon, Ph.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 21, 2006

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Constraint-Induced Movement Therapy (CIMT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe