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

NCT03474848 | Completed

• 1 other identifier: HABIT_BilateralCP
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Functional goals

  Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)

  6 months

• 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 Outcomes (3)

• Manual dexterity

  6 months

• Bimanual hand use

  6 months

• Manual dexterity

  6 months

Study Arms (2)

HABIT

EXPERIMENTAL

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

Other: HABIT

Conventional Occupational Therapy (OT)

ACTIVE COMPARATOR

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

Other: Conventional Occupational Therapy (OT)

Interventions

HABIT OTHER

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.

HABIT

Conventional Occupational Therapy (OT) OTHER

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.

Also known as: occupational therapy

Conventional Occupational Therapy (OT)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Related Publications (5)

• 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. doi: 10.1017/S0012162206002039.

  PMID: 17044964 BACKGROUND

• 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.

  PMID: 21700924 BACKGROUND

• 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.

  PMID: 28133725 BACKGROUND

• Brandao 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.

  PMID: 24376067 BACKGROUND

• de Brito Brandao 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.

  PMID: 23106987 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Marina B Brandão, Doctor

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 23, 2018
• Study Start: January 5, 2016
• Primary Completion: April 30, 2018
• Study Completion: March 30, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02