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

Cerebral Palsy Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03474848
Study type Interventional
Source Federal University of Minas Gerais
Contact
Status Completed
Phase N/A
Start date January 5, 2016
Completion date March 30, 2019
View Details
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