CompletedNot Applicable

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

6 participantsStarted 2014-07-01

Plain-language 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.

Who can participate

Age range3 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

Change of GAS(goal attainment scale)

Timeframe: 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)

Timeframe: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT

Trial details

NCT IDNCT04179682

SponsorChanghua Christian Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-10

View on ClinicalTrials.gov More Cerebral Palsy, Spastic trials

Who can participate

Age range3 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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

Change of GAS(goal attainment scale)

Timeframe: 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)

Timeframe: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT