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

Federal University of Minas Gerais

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Conventional Occupational Therapy (OT); Other: HABIT

Study type: Interventional

Funder types: Other

Identifiers

NCT03474848

HABIT_BilateralCP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

HABIT

Experimental group

Description:

Protocol of 90-hour of Hand-Arm Bimanual Intensive Training - 6 hours/day; 5 days/week, for 3 weeks

Treatment:

Other: HABIT

Conventional Occupational Therapy (OT)

Active Comparator group

Description:

Provision of 2 sessions/week (45 minutes), for 3 weeks

Treatment:

Other: Conventional Occupational Therapy (OT)