A prospective placebo controlled study of botulilium toxin (BOTOX) on gait disorder induced by spastic equinovarus foot.

• Conditions: Spastic equinus foot is a common dynamic deformity in patients with cerebral palsy. This dynamic deformity, mainly caused by spasticity of the soleus, gastrocnemius and tibialis posterior muscles, may lead to gait impairment.

• Registration Number: EUCTR2005-004685-17-BE
• Lead Sponsor: CUB - Hôpital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients will have unilateral spastic hemiplegia due to vascular or traumatic brain injury, with spastic drop foot impairing gait. Moreover, each patient will be included in a functional rehabilitation program (3 to 5 sessions/week of physiotherapy) during the study.
The inclusion criteria are :
?Unilateral clinical symptoms
?Equinus foot without fixed contracture
?Cerebral lesion superior to 2 months
?Independent gait with or without orthesis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The exclusion criteria are :
?Absence of prior orthopedic surgery in the lower extremities
?Absence of major cognitive disorders (MMS > 24)
?Absence of others factors interfering with gait as judged by investigators

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified