Treatment of Spastic Equinovarus Foot After Stroke

N/ACompletedNCT00199589

University Hospital, Limoges46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spastic Equinovarus

Interventions

Botulinic toxin (Botox)DRUG

Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Stroke interval \> 12 months * Age \< 18 years old * Pregnancy * Neuromuscular disease * Previous treatment with BTA * Fixed contractures impairing mobility * Mini-Mental Status Examination \< 25 * Aminosides treatment.

Locations (2)

Département de Médecine Physique et de Réadaptation

Bordeaux, France

Département de Médecine Physique et de Réadaptation, CHU Limoges

Limoges, France

Outcomes

Primary Outcomes

Plantar contact during walking

Secondary Outcomes

Gait velocity

Barthel index

MIF

Autosatisfaction by EVA

Asworth scale

Ankle range of motion

Data from ClinicalTrials.gov

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