Treatment of Spastic Equinovarus Foot After Stroke

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00199589
First received: September 14, 2005
Last updated: December 29, 2008
Last verified: December 2008
  Purpose

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199589

Locations
France
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
Allergan
Investigators
Principal Investigator: Jean-Yves Salle, MD University Hospital, Limoges
  More Information

No publications provided

ClinicalTrials.gov 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
Botox
Ankle foot orthosis

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Muscle Spasticity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Muscular Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014