Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03474848
Enrollment
40
Registered
2018-03-23
Start date
2016-01-05
Completion date
2019-03-30
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

cerebral palsy, rehabilitation, hand function, daily functioning, hand-arm bimanual intensive training

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.

Interventions

OTHERHABIT

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.

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.

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional goals6 monthsCanadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
Daily functioning6 monthsPediatric 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

MeasureTime frameDescription
Manual dexterity6 monthsJebsen 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)
Bimanual hand use6 monthsBoth Hand Assessment- score of bimanual hand function: score ranging from 0 to 100% (higher values, better outcome)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026