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Treatment of Spastic Equinovarus Foot After Stroke

Primary Purpose

Spastic Equinovarus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Botulinic toxin (Botox)
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Equinovarus focused on measuring Spastic equinovarus, Botox, Ankle foot orthosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Département de Médecine Physique et de Réadaptation
  • Département de Médecine Physique et de Réadaptation, CHU Limoges

Outcomes

Primary Outcome Measures

Plantar contact during walking

Secondary Outcome Measures

Gait velocity
Barthel index
MIF
Autosatisfaction by EVA
Asworth scale
Ankle range of motion

Full Information

First Posted
September 14, 2005
Last Updated
December 29, 2008
Sponsor
University Hospital, Limoges
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00199589
Brief Title
Treatment of Spastic Equinovarus Foot After Stroke
Official Title
Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Equinovarus
Keywords
Spastic equinovarus, Botox, Ankle foot orthosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinic toxin (Botox)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plantar contact during walking
Secondary Outcome Measure Information:
Title
Gait velocity
Title
Barthel index
Title
MIF
Title
Autosatisfaction by EVA
Title
Asworth scale
Title
Ankle range of motion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Salle, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de Médecine Physique et de Réadaptation
City
Bordeaux
Country
France
Facility Name
Département de Médecine Physique et de Réadaptation, CHU Limoges
City
Limoges
Country
France

12. IPD Sharing Statement

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Treatment of Spastic Equinovarus Foot After Stroke

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