The Effects of Hand-Arm Bimanual Intensive Training (HABIT) in Children With Bilateral Cerebral Palsy

February 4, 2020 updated by: MARINA B BRANDAO, Federal University of Minas Gerais

The Effects of Hand-Arm Bimanual Intensive Training (HABIT) in Hand Function and Daily Functioning of Children With Bilateral Cerebral Palsy: a Randomized Controlled Trial

Hand-Arm Bimanual Intensive Training (HABIT) has been shown to result in improvements in hand function and daily functioning of children with unilateral cerebral palsy (CP). Children with bilateral CP may also present difficulties to coordinate their hands to perform activities. Thus, HABIT may be a potential intervention for these individuals. We intend to examine the effects of HABIT on hand function and daily functioning of children with bilateral CP compared with conventional occupational therapy (OT). Our hypothesis is that children receiving HABIT will present larger improvements in manual dexterity and daily functioning as compared to conventional OT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design: Randomized Controlled Trial. Study Participants & Setting: Forty children with bilateral CP recruited from the Associação Mineira de Reabilitação, Belo Horizonte, Brazil.

Procedures: After being included in the study, children will be randomly assigned to a intervention group (n=20) or a control group (n=20). Children in the intervention group will receive a 90-hour (6 hours/day; 5 days/week, 3 weeks) of Hand-Arm Bimanual Intensive Training (HABIT) while children in control group will maintain their usual frequency of Occupational Therapy (OT) sessions (45 minutes/session, twice a week, for 3 weeks), focusing on functional training, stretching and sensory stimulation. All participants will be assessed by an examiner blinded to group allocation before and after the intervention period, as well as 6 months after the intervention (follow-up).

Statistical Analysis: A 2 (groups) x 3 (assessments) analysis of variance will test the effects of group, assessment and group x assessment interaction with a level of significance set at 0.05.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical diagnosis of bilateral CP;
  • Age between 4 and 17 years old;
  • Manual Ability Classification System (MACS) ranging from levels I to III;
  • Ability to understand verbal instructions.

Exclusion Criteria:

  • Botulinum toxin or surgery in upper limbs in the previous 6 months of 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HABIT
Protocol of 90-hour of Hand-Arm Bimanual Intensive Training - 6 hours/day; 5 days/week, for 3 weeks
Other: HABIT
Provision of individualized bimanual activities, individually chosen according to the child´s abilities, impairments and improvements in order to achieve success and to encourage bimanual use. Task difficulty is graded, focusing on enhancing the level of difficulty or speed, according to child's improvements. We use whole task practice (sequencing successive movements in the context of activities), part task practice (practice of specific components of the task in a repetitive sequence of time) and individualized functional goal training.
Active Comparator: Conventional Occupational Therapy (OT)
Provision of 2 sessions/week (45 minutes), for 3 weeks
Other: Conventional Occupational Therapy (OT)
Children will maintain the occupational therapy sessions with their therapists, without any change in their routine at the rehabilitation center. Strategies such as functional training, stretching and sensory stimulation are used.
Other Names:
  • occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional goals
Time Frame: 6 months
Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
6 months
Daily functioning
Time Frame: 6 months
Pediatric Evaluation Disability Inventory (PEDI) [Scales: (1)self-care functional skills : ranging from 0-63; higher values, better outcomes; (2) caregiver assistance in self care: ranging from 0-40; higher values, better outcome]
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual dexterity
Time Frame: 6 months
Jebsen Taylor Test of Hand Function (JTTHF): time to complete 6 hand function activities- score comprises the sum of time to complete the activities; ranging from 0-1080; higher values, worse outcome)
6 months
Bimanual hand use
Time Frame: 6 months
Both Hand Assessment- score of bimanual hand function: score ranging from 0 to 100% (higher values, better outcome)
6 months
Manual dexterity
Time Frame: 6 months
Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)
6 months

Collaborators and Investigators

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

Sponsor

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Marina B Brandão, Doctor, Federal University of Minas Gerais

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 (Actual)

January 5, 2016

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HABIT_BilateralCP

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.

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