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NCT Number: NCT03044080

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

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®).

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Key information

Conditions

Stroke Rehabilitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Stroke Rehabilitation Spasticity Management Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de l'Esperança

Barcelona, 08024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incobotulinumtoxinA

Drug

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.

OnabotulinumtoxinA

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2017
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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