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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Pilot Study of Constraint Induced Movement Therapy(CIMT） Intervention in Children With Hemiplegic Cerebral Palsy After Botulism Toxin Injection in Preschool Education

Conditions
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Cerebral Palsy, Spastic, Rehabilitation

Intervention / Treatment
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* Procedure: 40-hour constraint-induced movement therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4-week 2-hours/day CIMT program<br>a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education. | Procedure: 40-hour constraint-induced movement therapy<br>* 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.<br>|
| Active Comparator: 2-week 4-hours/day CIMT program<br>one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education. | Procedure: 40-hour constraint-induced movement therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Modified Ashworth Scale(MAS) | change of spasticity, from 0 to 4, higher scores mean a worse outcome. | 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT | 
| change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ) | hand function, from 0 to 144, higher scores mean a better outcome. | 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT | 
| Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ) | hand function. from 0 to 52, higher scores mean a better outcome. | 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT | 
| Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C) | ADL, from 0 to 73, higher scores mean a better outcome. | 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT | 
| 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. | 1 month after Botox injection, 2 months after CIMT and 4 months after CIMT | 
| 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. | 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT | 
| 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. | 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, constraint-induced movement therapy, botulinum toxin, rehabilitation, occupational therapy