Cerebral Palsy, Spastic, Rehabilitation
Conditions
Keywords
cerebral palsy, constraint-induced movement therapy, botulinum toxin, rehabilitation, occupational therapy
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.
Interventions
PROCEDURE40-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.
Sponsors
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| 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. |
Outcome results
None listed