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Treatment of Spastic Equinovarus Foot After Stroke

U

University of Limoges (UL)

Status

Completed

Conditions

Spastic Equinovarus

Treatments

Drug: Botulinic toxin (Botox)

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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