A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection
- Conditions
- RehabilitationCerebral Palsy, Spastic
- Interventions
- Procedure: 40-hour constraint-induced movement therapy
- Registration Number
- NCT04179682
- Lead Sponsor
- Changhua Christian Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2-week 4-hours/day CIMT program 40-hour constraint-induced movement therapy one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education. 4-week 2-hours/day CIMT program 40-hour constraint-induced movement therapy a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education.
- Primary Outcome Measures
Name Time Method change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ) 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.
Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C) 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.
Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA) 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.
Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA) 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.
change of Modified Ashworth Scale(MAS) 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.
Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ) 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.
Change of GAS(goal attainment scale) 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.
- Secondary Outcome Measures
Name Time Method