Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

October 30, 2024 updated by: Teachers College, Columbia University
A randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. Two treatment approaches are used: constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at TC Columbia University to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. Our center has been providing interventions camps for children with cerebral palsy since 1998. The interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. The aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches to engage children in fun activities. This study looks at what areas of the brain are responsible for recovery after intensive training. We are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study.

To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS will be used in this study, which is considered minimal risk and tolerable to children. If your child has a recurrent history of seizures after two years of age, he/she might not qualify.

Study Type

Interventional

Enrollment (Actual)

83

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 Center for Cerebral Palsy Research

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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of unilateral cerebral palsy

Exclusion Criteria:

  • Current medical illness unrelated to CP
  • Seizure disorder
  • Current use of medications know to lower the seizure threshold
  • Metallic object(s) in body, other than dental fillings
  • Pregnancy
  • Claustrophobia

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constraint Induced Movement Therapy
Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Other: Constraint-induced Movement Therapy
Experimental: Hand-Arm Bimanual Intensive Therapy
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Other: Hand-arm Bimanual Intensive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jebsen-Taylor Test of Hand Function
Time Frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
The JTTHF measures the time taken to complete six unimanual tasks, which include flipping cards, moving small objects, and lifting cans. The total score is the amount of time taken (in seconds) to complete all tasks. A lower score means a better outcome.
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Assisting Hand Assessment
Time Frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
The AHA is a validated test for measuring bimanual hand use in children with UE impairments. The AHA measures the use of the more affected hand in bimanual activities during a play-like testing session. Sessions were videotaped and scored off-site by a blinded evaluator. The AHA has excellent validity, reliability (0.97-0.99) and responsiveness to change. The AHA units were used for the analysis (range 0-100). The smallest detectable difference (SDD) for AHA is an improvement of at least 5 units. A higher score means a better outcome.
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Box and Blocks Test
Time Frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
The BBT measures how many blocks (2.5 cm3) an individual can move from one box, over a barrier, to an adjacent box in 1 min. Both hands were tested. The BBT is valid and reliable for children with CP. A higher score means a better outcome.
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
The COPM is a structured interview in which the individuals are asked to identify up to five functional goals. In this study, parents reported their child's functional goals. Parents rated how well children perform each goal (COPM-Performance), and how satisfied they were with the child's performance (COPM-Satisfaction). The same caregiver was interviewed before and after the intervention. A change of 2 or more points in each scale of COPM is considered a minimum clinically important difference (MCID). The COPM has been validated for parents of children with disabilities. A high score means a better outcome (range 0-10).
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

Collaborators and Investigators

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

Sponsor

Teachers College, Columbia University

Collaborators

Burke Medical Research Institute

Investigators

  • Principal Investigator: Andrew Gordon, Ph.D., Teachers College, Columbia University
  • Principal Investigator: Kathleen Friel, Ph.D., Burke Neurological Institute

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

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

September 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimated)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-140

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.

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