Treatment of Spastic Equinovarus Foot After Stroke

Spastic Equinovarus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199589
• Other study ID #: I01014
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: December 29, 2008
• Start date: October 2002
• Est. completion date: December 2007

Study information

• Verified date: December 2008
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Muscle Spasticity
• Spastic Equinovarus

Intervention

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.

Locations

Country	Name	City	State
France	Département de Médecine Physique et de Réadaptation	Bordeaux
France	Département de Médecine Physique et de Réadaptation, CHU Limoges	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Allergan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plantar contact during walking
Secondary	Gait velocity
Secondary	Barthel index
Secondary	MIF
Secondary	Autosatisfaction by EVA
Secondary	Asworth scale
Secondary	Ankle range of motion