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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: HABIT; Other: Conventional Occupational Therapy (OT)

• Registration Number: NCT03474848
• Lead Sponsor: Federal University of Minas Gerais

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.

Study Timeline

• Study Start: 2016-01-05
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Primary Completion: 2018-04-30
• Study Completion: 2019-03-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HABIT	HABIT	Protocol of 90-hour of Hand-Arm Bimanual Intensive Training - 6 hours/day; 5 days/week, for 3 weeks
Conventional Occupational Therapy (OT)	Conventional Occupational Therapy (OT)	Provision of 2 sessions/week (45 minutes), for 3 weeks

Primary Outcome Measures

Name	Time	Method
Functional goals	6 months	Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
Daily functioning	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 Outcome Measures

Name	Time	Method
Manual dexterity	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)
Bimanual hand use	6 months	Both Hand Assessment- score of bimanual hand function: score ranging from 0 to 100% (higher values, better outcome)