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Completed

NCT Number: NCT00199589

Treatment of Spastic Equinovarus Foot After Stroke

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

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Key information

Conditions

Spastic Equinovarus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département de Médecine Physique et de Réadaptation, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinic toxin (Botox)

Drug

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 outcomes

  1. Plantar contact during walking

Secondary outcomes

  1. Gait velocity

  2. Barthel index

  3. MIF

  4. Autosatisfaction by EVA

  5. Asworth scale

  6. Ankle range of motion

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Allergan

Registry information

Official study title

Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection

Important dates

Study start
2002
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Dec 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.