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Treatment of Spastic Equinovarus Foot After Stroke

This study has been completed.
Information provided by:
University Hospital, Limoges Identifier:
First received: September 14, 2005
Last updated: December 29, 2008
Last verified: December 2008

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

Condition Intervention
Spastic Equinovarus
Drug: Botulinic toxin (Botox)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection

Resource links provided by NLM:

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Plantar contact during walking

Secondary Outcome Measures:
  • Gait velocity
  • Barthel index
  • MIF
  • Autosatisfaction by EVA
  • Asworth scale
  • Ankle range of motion

Estimated Enrollment: 46
Study Start Date: October 2002
Study Completion Date: December 2007
Intervention Details:
    Drug: 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.
Detailed 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00199589

Département de Médecine Physique et de Réadaptation
Bordeaux, France
Département de Médecine Physique et de Réadaptation, CHU Limoges
Limoges, France
Sponsors and Collaborators
University Hospital, Limoges
Principal Investigator: Jean-Yves Salle, MD University Hospital, Limoges
  More Information

No publications provided Identifier: NCT00199589     History of Changes
Other Study ID Numbers: I01014
Study First Received: September 14, 2005
Last Updated: December 29, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Spastic equinovarus
Ankle foot orthosis

Additional relevant MeSH terms:
Equinus Deformity
Congenital Abnormalities
Foot Deformities
Foot Deformities, Acquired
Foot Deformities, Congenital
Limb Deformities, Congenital
Lower Extremity Deformities, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2014