Treatment of Spastic Equinovarus Foot After Stroke

University of Limoges (UL)

Status

Completed

Conditions

Spastic Equinovarus

Treatments

Drug: Botulinic toxin (Botox)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00199589

I01014

Details and patient eligibility

About

This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

Full description

This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles [300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection]. The patients are followed for one year after treatment.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
Ability to walk for at least 10 meters with or without aid
Stroke interval < 12 months
Age > 18 years old
Weight > 30 kg and < 100 kg
Written informed consent

Exclusion criteria