Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot
Condition: Stroke Rehabilitation; Stroke Rehabilitation Spasticity Management
MeSH terms: Muscle Spasticity; Clubfoot; Stroke
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): IncobotulinumtoxinA; OnabotulinumtoxinA
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Botulinum Toxins, Type A; incobotulinumtoxinA; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Walking Disorder; Stroke; Botulinum Toxin; Spasticity