Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot
- Conditions
- Stroke RehabilitationStroke Rehabilitation Spasticity Management
- Interventions
- Registration Number
- NCT03044080
- Lead Sponsor
- Parc de Salut Mar
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- First-ever Ischemic or haemorrhagic stroke
- Time since stroke onset: >6months
- Hemiparesis with equinovarus foot
- No previous BoNT/A
- Non-ambulant patients
- Medical contraindications for BoNT/A use that appear in the product information sheet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IncobotulinumtoxinA IncobotulinumtoxinA Injection of 200-300 units of IncobotulinumtoxinA (Xeomin ®) OnabotulinumtoxinA OnabotulinumtoxinA Injection of 200-300 units of onabotulinumtoxiA (Botox®)
- Primary Outcome Measures
Name Time Method Change in walking speed Baseline and monthly during 18 months Walking speed, expressed in m/s, is assessed in a 10-m corridor
- Secondary Outcome Measures
Name Time Method Change in spasticity assessed with the Modified Ashworth Scale Baseline and monthly during 18 months Spasticity assessed with the Modified Ashworth Scale (range 0-5)
Change in walking disability assessed with the Scandinavian Stroke Scale Baseline and monthly during 18 months Walking disability is assessed with the Scandinavian Stroke Scale
Change in step length Baseline and monthly during 18 months Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis
Change in step time Baseline and monthly during 18 months Step time (Temporal gait parameter) is expressed in seconds and assessed with instrumented gait analysis
Change in functional ambulation ability assessed with the Modified Walking Categories Baseline and monthly during 18 months Functional ambulation ability is assessed with the Modified Walking Categories
Trial Locations
- Locations (1)
Hospital de l'Esperança
🇪🇸Barcelona, Spain