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NCT Number: NCT04179682

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

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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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Rehabilitation

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

40-hour constraint-induced movement therapy

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.

Primary outcomes

  1. change of Modified Ashworth Scale(MAS)

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

    change of spasticity, from 0 to 4, higher scores mean a worse outcome.

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

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

    hand function, from 0 to 144, higher scores mean a better outcome.

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

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

    hand function. from 0 to 52, higher scores mean a better outcome.

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

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

    ADL, from 0 to 73, higher scores mean a better outcome.

  5. Change of GAS(goal attainment scale)

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

    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.

  6. Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)

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

    From 0 to 14, higher scores mean a worse outcome.

  7. Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)

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

    From 0 to 14, higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2019
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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