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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
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   (Adult, Senior)
Sexes Eligible for Study:   All
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.
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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 Identifier: NCT00199589     History of Changes
Other Study ID Numbers: I01014
Study First Received: September 14, 2005
Last Updated: December 29, 2008

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

Additional relevant MeSH terms:
Muscle Spasticity
Equinus Deformity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Foot Deformities, Congenital
Foot Deformities
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 25, 2017