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临床试验/NCT05874154
NCT05874154招募中不适用

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

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
4
主要终点
Evolution of the value of Goal Attainment Scaling

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Tibial nerve selective neurotomy

Experimental

干预措施: Tibial nerve selective neurotomy (Procedure)

Botulinum toxin injection

Active Comparator

干预措施: Botulinum toxin injection (Drug)

结局指标

主要结局

Evolution of the value of Goal Attainment Scaling

时间窗: through study completion, 14 months

Primary endpoint will be assessed using the Goal Attainment Scaling before treatment and the evaluation at the endpoint. Goals are defined before initiation of treatment, and attainment at study end is scored using a 5-point scale (-2, -1, 0, 1, 2); -2: pretreatment level, -1: less than expected; 0: expected goal; +1: somewhat more than expected; +2: best possible outcome expected

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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