A Phase 4 interventional study of IncobotulinumtoxinA and OnabotulinumtoxinA in Stroke Rehabilitation and Stroke Rehabilitation Spasticity Management, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Parc de Salut Mar · Phase 4, Interventional, and Treatment
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®).
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Injection of 200-300 units of IncobotulinumtoxinA (Xeomin ®)
Drug: IncobotulinumtoxinA
Injection of 200-300 units of onabotulinumtoxiA (Botox®)
Drug: OnabotulinumtoxinA
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.
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.
Change in walking speed
Walking speed, expressed in m/s, is assessed in a 10-m corridor
Time frame: Baseline and monthly during 18 months
Change in spasticity assessed with the Modified Ashworth Scale
Spasticity assessed with the Modified Ashworth Scale (range 0-5)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and monthly during 18 months
Plan to share: No
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar