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

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Cerebral Palsy, Spastic
• Intervention / Treatment: Procedure: 40-hour constraint-induced movement therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4-week 2-hours/day CIMT program; a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education.	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.
Active Comparator: 2-week 4-hours/day CIMT program; one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)	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
Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)	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
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
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
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
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

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): February 10, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; occupational therapy; cerebral palsy; botulinum toxin; constraint-induced movement therapy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Brain Damage, Chronic; Neuromuscular Diseases; Foodborne Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Junction Diseases; Clostridium Infections; Poisoning; Neurotoxicity Syndromes; Cerebral Palsy; Paralysis; Botulism
• Other Study ID Numbers: 130210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No