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

C

Changhua Christian Medical Foundation

Status

Completed

Conditions

Cerebral Palsy, Spastic
Rehabilitation

Treatments

Procedure: 40-hour constraint-induced movement therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

3 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

6 participants in 2 patient groups

4-week 2-hours/day CIMT program
Active Comparator group
Description:
a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education.
Treatment:
Procedure: 40-hour constraint-induced movement therapy
2-week 4-hours/day CIMT program
Active Comparator group
Description:
one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education.
Treatment:
Procedure: 40-hour constraint-induced movement therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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