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 range

3 Years – 6 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

3 Years – 6 Years

Sex

ALL

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