Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot

Study Overview
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Brief Summary
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Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in three successive infiltrations at 6-month intervals, checking if the sustainability of the effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).

Detailed Description
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Spasticity is present in 38% of patients at six months after stroke. Equinovarus foot, with or without claw toes and striatal foot, is especially common. There is a weak to moderate evidence in favor of the use of botulinum neurotoxin type A (BoNT/A) in the equinovarus foot, stiff-knee and in other patterns that may interfere with gait ability. Specifically, BoNT/A increases walking speed in stroke patients with spastic equinovarus foot. Repeated use of BoNT/A may lead to the appearance of neutralizing antibodies, so its effect may decrease over successive infiltrations. Among the differential characteristics of incobotulinumtoxinA (Xeomin®) there is a reduced inactivated botulinum neurotoxin content and the lack of complexing proteins, which would diminish antigenicity and not suppose a decrease of the effect before successive infiltrations. The objective of this project is to determine the effect on walking speed of repeated use of BoNT/A in post-stroke spinal equinovarus foot in three consecutive injections at 6-month intervals and to investigate whether the sustainability of the effect is greater in incobotulinumtoxinA (Xeomin®) than in onabotulinumtoxinA (Botox®). All patients will receive 200-300 units of BoNT/A (Xeomin ® or Botox ®) that will be distributed according to the individual clinical pattern of spastic equinovarus foot.

Official Title
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Effects of Repeated Use of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot in Stroke Patients: A Randomized Clinical Trial

Conditions
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Stroke Rehabilitation, Stroke Rehabilitation Spasticity Management

Intervention / Treatment
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* Drug: IncobotulinumtoxinA
* Drug: OnabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-ever Ischemic or haemorrhagic stroke Time since stroke onset: >6months Hemiparesis with equinovarus foot No previous BoNT/A Exclusion Criteria: Non-ambulant patients Medical contraindications for BoNT/A use that appear in the product information sheet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IncobotulinumtoxinA<br>Injection of 200-300 units of IncobotulinumtoxinA (Xeomin ®) | Drug: IncobotulinumtoxinA<br>* Three consecutive injections of 200-300 units of IncobotulinumtoxinA (Xeomin ®) under ultrasound guidance. The IncobotulinumtoxinA will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus.<br>|
| Active Comparator: OnabotulinumtoxinA<br>Injection of 200-300 units of onabotulinumtoxiA (Botox®) | Drug: OnabotulinumtoxinA<br>* ree consecutive injections of 200-300 units of OnabotulinumtoxinA (Botox ®) under ultrasound guidance. The BoNT/A will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | Walking speed, expressed in m/s, is assessed in a 10-m corridor | Baseline and monthly during 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spasticity assessed with the Modified Ashworth Scale | Spasticity assessed with the Modified Ashworth Scale (range 0-5) | Baseline and monthly during 18 months | 
| Change in walking disability assessed with the Scandinavian Stroke Scale | Walking disability is assessed with the Scandinavian Stroke Scale | Baseline and monthly during 18 months | 
| Change in functional ambulation ability assessed with the Modified Walking Categories | Functional ambulation ability is assessed with the Modified Walking Categories | Baseline and monthly during 18 months | 
| Change in step time | Step time (Temporal gait parameter) is expressed in seconds and assessed with instrumented gait analysis | Baseline and monthly during 18 months | 
| Change in step length | Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis | Baseline and monthly during 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Botulinum Toxin, Spasticity, Walking Disorder