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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HABIT
Conventional Occupational Therapy (OT)
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, rehabilitation, hand function, daily functioning, hand-arm bimanual intensive training

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HABIT

    Conventional Occupational Therapy (OT)

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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)
    Bimanual hand use
    Both Hand Assessment- score of bimanual hand function: score ranging from 0 to 100% (higher values, better outcome)
    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)

    Full Information

    First Posted
    March 15, 2018
    Last Updated
    February 4, 2020
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03474848
    Brief Title
    The Effects of Hand-Arm Bimanual Intensive Training (HABIT) in Children With Bilateral Cerebral Palsy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2016 (Actual)
    Primary Completion Date
    April 30, 2018 (Actual)
    Study Completion Date
    March 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    cerebral palsy, rehabilitation, hand function, daily functioning, hand-arm bimanual intensive training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HABIT
    Arm Type
    Experimental
    Arm Description
    Protocol of 90-hour of Hand-Arm Bimanual Intensive Training - 6 hours/day; 5 days/week, for 3 weeks
    Arm Title
    Conventional Occupational Therapy (OT)
    Arm Type
    Active Comparator
    Arm Description
    Provision of 2 sessions/week (45 minutes), for 3 weeks
    Intervention Type
    Other
    Intervention Name(s)
    HABIT
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Occupational Therapy (OT)
    Other Intervention Name(s)
    occupational therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Functional goals
    Description
    Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
    Time Frame
    6 months
    Title
    Daily functioning
    Description
    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]
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Manual dexterity
    Description
    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)
    Time Frame
    6 months
    Title
    Bimanual hand use
    Description
    Both Hand Assessment- score of bimanual hand function: score ranging from 0 to 100% (higher values, better outcome)
    Time Frame
    6 months
    Title
    Manual dexterity
    Description
    Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marina B Brandão, Doctor
    Organizational Affiliation
    Federal University of Minas Gerais
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17044964
    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. doi: 10.1017/S0012162206002039.
    Results Reference
    background
    PubMed Identifier
    21700924
    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.
    Results Reference
    background
    PubMed Identifier
    28133725
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24376067
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23106987
    Citation
    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.
    Results Reference
    background

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

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