Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

May 4, 2017 updated by: Teachers College, Columbia University

A randomized control trial to test the efficacy of a new treatment involving intensive home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive home-based functional lower-limb training in children with hemiplegia. The protocols have been developed at TC Columbia University to be child friendly and draw upon the investigators experience since 1998 with intensive movement therapy in children with cerebral palsy. The aim is to promote either the use/coordination of movement of the hands or improve lower-limb balance, strength, and function. Caregivers will be trained at the investigator center and then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of activities with their child in their own home. The activities will be supervised by the investigators team via computer. Participants do NOT need to live in the New York City area, but a one-time weekend visit to the investigators center is required for training. All measurement and treatment is performed in the home.

Participants are randomized to receive either HABIT or lower-limb training. If caregivers wish, they may chose to be crossed over at the end of the study and trained to receive the other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more information: http://www.tc.edu/centers/cit/

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are currently recruiting children with hemiplegia between the ages of 2.5 to 12 years of age to participate in a study examining the effects of extensive practice on affected hand/arm use and lower- limb use. This is a research study that will teach caregivers how to administer either hand-arm bimanual intensive training (HABIT) or lower-limb intensive training in their own home. HABIT aims to improve the use and coordination of both arms in daily function, particularly during the performance of bimanual activities (i.e. buttoning a shirt, cutting with scissors). Lower-limb intensive training aims to improve the quality of lower-limb functioning with a particular focus on functional activities (i.e. getting up from a chair, walking, climbing stairs).

What does participation entail?

  • Being randomized to learn to provide either intensive lower- or upper-limb activities in your own home (training will be provided over a a weekend session at our center)
  • Getting trained to administer some basic upper- and lower-limb assessments in your own home
  • Completing 90 hours of activities over a period of 9 weeks (2 hrs/day, 5 days/week; does not have to be 2 consecutive hours for daily activities)
  • Videoconferencing online with a project supervisor at least 1 hour per week during activities
  • Learning how to assess your child's motor function for posttesting.

Can I choose to receive upper or lower extremity training if my child qualifies?

• Unfortunately not, it must be randomly assigned as each group will be compared to the other. However, the investigators can provide training tips after completion of the study.

What if my child does not qualify?

  • There may be opportunities at a later date or for another study.
  • Please contact us at (212)-678-3332 or cpresearch@tc.columbia.edu if you have any questions.

Study Type

Interventional

Enrollment (Actual)

24

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children between the ages of 2.5 - 12 years with hemiplegia; hemiplegia due to result of prenatal stroke, brain lesion, or malformation (or within the two years of life).
  • Children that have the ability to grasp or release objects with the affected hand
  • Children who are able to walk independently without the assistance of a device
  • Children that have the cognitive capability to follow simple instructions and interact in play activities 2 hours per day with a parent/caregiver.
  • Caregivers willing to commit to the entire intervention period of 90 hours over 9 weeks
  • Caregivers able to provide one-on-one attention to child during the daily two hours of activities (note: because this is part of a research study, we can only train one caregiver per household)

Exclusion Criteria:

  • Children that have received Botox or are planning any new treatment within 6 mos. of enrollment in the 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand-Arm Bimanual Intensive Therapy (HABIT)
HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Experimental: Intensive Functional Lower-Limb Training
lower-limb function, strength training, balance, PT, OT, rehab
Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisting Hand Assessment
Time Frame: Change from baseline to 9 weeks
measure of bimanual hand-use in spontaneous play setting
Change from baseline to 9 weeks
10 Meter walk test
Time Frame: Change from baseline to 9 weeks
measures child's velocity when walking over 10 meters
Change from baseline to 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisting Hand Assessment
Time Frame: Change from baseline to 6 months
measure of bimanual hand-use in spontaneous play setting
Change from baseline to 6 months
10 Meter walk test
Time Frame: Change from baseline to 6 months
measures child's velocity when walking over 10 meters
Change from baseline to 6 months

Collaborators and Investigators

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

Sponsor

Teachers College, Columbia University

Investigators

  • Study Director: Andrew Gordon, Ph.D., Teachers College, 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

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

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-219CR

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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