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 Details — Status: Completed

Administrative data

• NCT number: NCT03474848
• Other study ID #: HABIT_BilateralCP
• Status: Completed
• Phase: N/A
• Start date: January 5, 2016
• Est. completion date: March 30, 2019

Study information

• Verified date: February 2020
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2019
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• HABIT
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.
• Conventional Occupational Therapy (OT)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

References & Publications (5)

Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30. — View Citation

Brandão MB, Ferre C, Kuo HC, Rameckers EA, Bleyenheuft Y, Hung YC, Friel K, Gordon AM. Comparison of Structured Skill and Unstructured Practice During Intensive Bimanual Training in Children With Unilateral Spastic Cerebral Palsy. Neurorehabil Neural Repair. 2014 Jun;28(5):452-61. doi: 10.1177/1545968313516871. Epub 2013 Dec 27. — View Citation

Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. Review. — View Citation

de Brito Brandão M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622. — View Citation

Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional goals	Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)	6 months
Primary	Daily functioning	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]	6 months
Secondary	Manual dexterity	Jebsen 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)	6 months
Secondary	Bimanual hand use	Both Hand Assessment- score of bimanual hand function: score ranging from 0 to 100% (higher values, better outcome)	6 months
Secondary	Manual dexterity	Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)	6 months