Clinical trial NCT04179682: A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection
Official title: The Pilot Study of Constraint Induced Movement Therapy(CIMT） Intervention in Children With Hemiplegic Cerebral Palsy After Botulism Toxin Injection in Preschool Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Rehabilitation
Keywords: cerebral palsy
constraint-induced movement therapy
botulinum toxin
rehabilitation
occupational therapy
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of Modified Ashworth Scale(MAS)
timeFrame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
measure: change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
timeFrame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
measure: Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)
timeFrame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
measure: Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)
timeFrame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
measure: Change of GAS(goal attainment scale)
timeFrame: 1 month after Botox injection, 2 months after CIMT and 4 months after CIMT
measure: Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
timeFrame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
measure: Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
timeFrame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: