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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000530

Enrollment

Registered

2012-09-10

Start date

2012-09-17

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine : Name: Medytox ® injection/usage: Normal saline mix (200U/4cc NS mix)/dose: 1V (200U)/duration: one time/administration: IM apply muscle group : gastrocnemius, tibialis posterior m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
hindfoot contact width	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactSoo Jin Jung

Yonsei University Health System, Severance Hospital

Outcome results