Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach

Обзор

In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults. Incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. Spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. It has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. In hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. These abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfort (pain) and may become irreducible (tendon shortening) if not treated. The purpose of this study is to compare the interest of each treatment (BoNT-A versus STN) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients. This study aims to confirm a greater reduction of calf muscles spasticity after STN as compared to BoNT-A, as observed in the only published monocentric randomized controlled trial. Our study originality is to perform a multi-center RCT with a pre-established sample size. This study will also quantify progress towards personal goals using the goal attainment scaling (GAS) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.

Вмешательства

• Процедура Tibial nerve selective neurotomy
  Patients in the STN group will undergo a pre-anaesthetic visit before surgery to validate the possibility of general anesthesia. The surgery will be performed at maximum 3 months after inclusion. The muscles that have been defined pre-randomization will be targeted by the surgery. The duration of the surgery is about 1 hour and 30 minutes.
• Препарат Botulinum toxin injection
  Patients in the BoNT group will be treated with BoNT A under electromyography, electrical stimulation and/or ultrasound guidance (V0). In the absence of scientific evidence between the efficacy of onabotulinumtoxin A and abobotulinumtoxin A, physician will be free to choose between these two BoNT formulation which are both authorized for the treatment of lower limb spasticity. The physician will determine the muscles targeted by the BoNT (gastrocnemius and soleus for equinus, posterior tibialis

Первичные конечные точки

• Evolution of the value of Goal Attainment Scaling [Срок оценки: through study completion, 14 months]

Вторичные конечные точки (10)

• Evolution of Functional outcomes [Срок оценки: through study completion, 14 months]
• Tardieu's scale [Срок оценки: through study completion, 14 months]
• Modified Ashworth scale [Срок оценки: through study completion, 14 months]
• Evolution of ankle motion range [Срок оценки: through study completion, 14 months]
• Proportion of patients with antispastic drug [Срок оценки: through study completion, 14 months]
• measure of pain level [Срок оценки: through study completion, 14 months]
• Proportion of patients with adverse event [Срок оценки: through study completion, 14 months]
• Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8) [Срок оценки: through study completion, 14 months]
• 10 meter walk test - speed [Срок оценки: through study completion, 14 months]
• 10 meter walk test - distance [Срок оценки: through study completion, 14 months]

Критерии участия

Критерии включения

• Adult patients (older than 18 years)
• Man and woman
• Hemiparesis secondary to stroke (delay from stroke > 1 year)
• Foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and /or one of the following muscles: tibialis posterior, flexor digitorum and hallucis longus muscles.
• Spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in passive or active ankle dorsal flexion.
• Covered by National French insurance
• Able to understand French and the purpose of the study
• Informed consent signed by the patient or consent obtained from a relative or trusted person of the patient

Критерии исключения

• Known sensitivity to BoNT or botulinum toxin A excipients
• Contraindication to surgery under general anesthesia
• History of myasthenia
• Pregnant woman (confirmed by urinary test) or breastfeeding
• Patient under legal protection
• Patients unable to follow the requirement of the study according to the investigator or supported by a family member

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Hôpital Pierre Wertheimer — Bron
• AP-HP — Clichy
• CHU de Nantes — Nantes
• Hôpital Henry Gabrielle — Saint-Genis-Laval

Идентификаторы

NCT: NCT05874154 · 69HCL22_0905

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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