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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 40
- Primary Endpoint
- Functional goals
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
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.
Investigators
MARINA B BRANDAO
Professor
Federal University of Minas Gerais
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Functional goals
Time Frame: 6 months
Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
Daily functioning
Time Frame: 6 months
Pediatric Evaluation Disability Inventory (PEDI) \[Scales: (1)self-care functional skills : ranging from 0-63; higher values, better outcomes; (2) caregiver assistance in self care: ranging from 0-40; higher values, better outcome\]
Secondary Outcomes
- Manual dexterity(6 months)
- Bimanual hand use(6 months)