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

Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179682
• Other study ID #: 130210
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2019
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 1, 2019
• Est. primary completion date: February 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Botulism
• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis
• Rehabilitation

Intervention

Procedure:
• 40-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Modified Ashworth Scale(MAS)	change of spasticity, from 0 to 4, higher scores mean a worse outcome.	1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
Primary	change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMS?)	hand function, from 0 to 144, higher scores mean a better outcome.	1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
Primary	Change of grasping in Peabody-Developmental Motor Scales(PDMS?)	hand function. from 0 to 52, higher scores mean a better outcome.	1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
Primary	Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)	ADL, from 0 to 73, higher scores mean a better outcome.	1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
Primary	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.	1 month after Botox injection, 2 months after CIMT and 4 months after CIMT
Primary	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.	1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
Primary	Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)	From 0 to 14, higher scores mean a worse outcome.	1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT