Stroke Rehabilitation, Stroke Rehabilitation Spasticity Management
Conditions
Keywords
Walking Disorder, Stroke, Botulinum Toxin, Spasticity
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.
Interventions
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.
DRUGOnabotulinumtoxinA
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.
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in walking speed | Baseline and monthly during 18 months | Walking speed, expressed in m/s, is assessed in a 10-m corridor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 step length | Baseline and monthly during 18 months | Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis |
Countries
Spain
Outcome results
None listed