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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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 Summary:

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.


Sponsor: Parc de Salut Mar

Current Primary Outcome: Change in walking speed [ Time Frame: Baseline and monthly during 18 months ]

Walking speed, expressed in m/s, is assessed in a 10-m corridor


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in spasticity assessed with the Modified Ashworth Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and monthly during 18 months ]
    Functional ambulation ability is assessed with the Modified Walking Categories
  • Change in step time [ Time Frame: 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 [ Time Frame: Baseline and monthly during 18 months ]
    Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis


Original Secondary Outcome: Same as current

Information By: Parc de Salut Mar

Dates:
Date Received: February 1, 2017
Date Started: January 1, 2015
Date Completion: June 30, 2017
Last Updated: February 3, 2017
Last Verified: February 2017