Treatment of Spastic Equinovarus Foot After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Spastic Equinovarus

Keywords

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Spastic equinovarus Botox Ankle foot orthosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Botulinic toxin (Botox)

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Yves Salle, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Département de Médecine Physique et de Réadaptation

Bordeaux, , France

Site Status

Département de Médecine Physique et de Réadaptation, CHU Limoges

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I01014

Identifier Type: -

Identifier Source: org_study_id