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

NCT04179682 | Completed

• 1 other identifier: 130210
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy, Spastic; Rehabilitation

Keywords

cerebral palsy; constraint-induced movement therapy; botulinum toxin; rehabilitation; occupational therapy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

4-week 2-hours/day CIMT program

ACTIVE COMPARATOR

a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education.

Procedure: 40-hour constraint-induced movement therapy

2-week 4-hours/day CIMT program

ACTIVE COMPARATOR

one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education.

Procedure: 40-hour constraint-induced movement therapy

Interventions

40-hour constraint-induced movement therapy PROCEDURE

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.

2-week 4-hours/day CIMT program; 4-week 2-hours/day CIMT program

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: July 1, 2014
• Primary Completion: February 10, 2019
• Study Completion: October 1, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share