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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2019-10-01

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.

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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.

Conditions

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Cerebral Palsy, Spastic Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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4-week 2-hours/day CIMT program

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

Group Type ACTIVE_COMPARATOR

40-hour constraint-induced movement therapy

Intervention Type PROCEDURE

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.

2-week 4-hours/day CIMT program

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

Group Type ACTIVE_COMPARATOR

40-hour constraint-induced movement therapy

Intervention Type PROCEDURE

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.

Interventions

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40-hour constraint-induced movement therapy

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No