The effect of botulinum toxin-A(BTX-A) injection for equinovarus deformity in children with unilateral cerebral palsy.

Not Applicable

• Conditions: Diseases of the nervous system

• Registration Number: KCT0000530
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

? Cerebral palsy, spastic hemiplegia (age: 2~18 years)
? dynamic equinovarus foot deformity
? The patient able to independent gait (GMFCS classification I, II, III)
? ankle spasticity more than modified Ashworth scale grade 1
? the patient with himself and his legal guardian signed the consent form with voluntary participation.

Exclusion Criteria

? The botulinum toxin injections within 3 months before the start of the study
? Neurosurgery, orthopedic surgery within 3 months before the start of the study, or scheduled within study duration.
? Previous history like hypersensitivity for botulinum toxin
? Severe athetoid cerebral palsy
? Participate in other clinical trial
? Likely to conceive
? Take prohibited drugs to combination, and not able to stopped
-muscle relaxant: tubocurarine chrolide , sodium dantrolate, baclofen, etc.
-Spectinomycin HCl
-Aminoglycosides : Gentamicin sulfate, Neomycin sulfate, etc
-Polypeptides: Polymyxin B sulfate, etc
-Tetracycline
-lincosamides
-Anticholinergics: scopolamine butylbromide, trihexyphenidyl HCl, etc
-Benzodiazepines or similar drugs: : diazepam, etizolam
? Judged to be unsuitable in this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hindfoot contact width

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth scale;Modified Tardieu scale;Foot contact pattern;Center of pressure index;COP trajectory;Pressure-time integral;Angle of knee joint in initial contact in the sagittal plane ;Maximal angle of knee extension in stance phase in the sagittal plane ;Maximal angle of ankle dorsiflexion in the sagittal plane ;Maximal angle of ankle plantarflexion in the sagittal plane ;Maximal moment of ankle plantarflexion in the sagittal plane ;Mean moment of ankle plantarflexion in the sagittal plane