search
Back to results

A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection

Primary Purpose

Cerebral Palsy, Spastic, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
40-hour constraint-induced movement therapy
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring cerebral palsy, constraint-induced movement therapy, botulinum toxin, rehabilitation, occupational therapy

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hemiplegic or quadriplegic CP children were under a regular rehabilitation program with BoNT-A injections. They were classified as Gross Motor Function Classification System level I and II, aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was greater than 10 degrees.

Exclusion Criteria:

Children were excluded if they (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    4-week 2-hours/day CIMT program

    2-week 4-hours/day CIMT program

    Arm Description

    a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education.

    one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education.

    Outcomes

    Primary Outcome Measures

    change of Modified Ashworth Scale(MAS)
    change of spasticity, from 0 to 4, higher scores mean a worse outcome.
    change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
    hand function, from 0 to 144, higher scores mean a better outcome.
    Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)
    hand function. from 0 to 52, higher scores mean a better outcome.
    Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)
    ADL, from 0 to 73, higher scores mean a better outcome.
    Change of GAS(goal attainment scale)
    GAS included 2 playing goals and 2 self-care goals.The goals were decided by the occupation therapist, the preschool teacher and the major caregiver. From (-2) to 2, higher scores mean a better outcome.
    Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
    From 0 to 14, higher scores mean a worse outcome.
    Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
    From 0 to 14, higher scores mean a worse outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2019
    Last Updated
    November 26, 2019
    Sponsor
    Changhua Christian Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04179682
    Brief Title
    A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection
    Official Title
    The Pilot Study of Constraint Induced Movement Therapy(CIMT） Intervention in Children With Hemiplegic Cerebral Palsy After Botulism Toxin Injection in Preschool Education
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    February 10, 2019 (Actual)
    Study Completion Date
    October 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changhua Christian Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education.
    Detailed Description
    This study was designed to be a pilot study on the use of 4-week 2-hours/day and 2-week 4-hours/day CIMT interventions in children with hemiplegic CP after a BoNT-A injection in preschool education, and compared the effects and psychological stress of CP children relative to the 2 CIMT programs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Spastic, Rehabilitation
    Keywords
    cerebral palsy, constraint-induced movement therapy, botulinum toxin, rehabilitation, occupational therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    4-week 2-hours/day CIMT program
    Arm Type
    Active Comparator
    Arm Description
    a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education.
    Arm Title
    2-week 4-hours/day CIMT program
    Arm Type
    Active Comparator
    Arm Description
    one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education.
    Intervention Type
    Procedure
    Intervention Name(s)
    40-hour constraint-induced movement therapy
    Intervention Description
    Participants were randomly allocated to 1 of 2 CIMT programs (40 hours): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection.
    Primary Outcome Measure Information:
    Title
    change of Modified Ashworth Scale(MAS)
    Description
    change of spasticity, from 0 to 4, higher scores mean a worse outcome.
    Time Frame
    1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
    Title
    change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
    Description
    hand function, from 0 to 144, higher scores mean a better outcome.
    Time Frame
    1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
    Title
    Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)
    Description
    hand function. from 0 to 52, higher scores mean a better outcome.
    Time Frame
    1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
    Title
    Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)
    Description
    ADL, from 0 to 73, higher scores mean a better outcome.
    Time Frame
    1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
    Title
    Change of GAS(goal attainment scale)
    Description
    GAS included 2 playing goals and 2 self-care goals.The goals were decided by the occupation therapist, the preschool teacher and the major caregiver. From (-2) to 2, higher scores mean a better outcome.
    Time Frame
    1 month after Botox injection, 2 months after CIMT and 4 months after CIMT
    Title
    Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
    Description
    From 0 to 14, higher scores mean a worse outcome.
    Time Frame
    1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
    Title
    Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
    Description
    From 0 to 14, higher scores mean a worse outcome.
    Time Frame
    1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hemiplegic or quadriplegic CP children were under a regular rehabilitation program with BoNT-A injections. They were classified as Gross Motor Function Classification System level I and II, aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was greater than 10 degrees. Exclusion Criteria: Children were excluded if they (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection

    We'll reach out to this number within 24 hrs