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

Changhua Christian Hospital6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy, Spastic Rehabilitation

Interventions

40-hour constraint-induced movement therapyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

change of Modified Ashworth Scale(MAS)

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

change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)

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

Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)

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

Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)

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

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.

Time frame: 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.

Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.