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
- Conditions
- Post Stroke SeizureSpastic Foot
- Interventions
- Drug: Botulinum toxin injectionProcedure: Tibial nerve selective neurotomy
- Registration Number
- NCT05874154
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum toxin injection Botulinum toxin injection - Tibial nerve selective neurotomy Tibial nerve selective neurotomy -
- Primary Outcome Measures
Name Time Method Evolution of the value of Goal Attainment Scaling 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
- Secondary Outcome Measures
Name Time Method Tardieu's scale through study completion, 14 months Tardieu's scale assesses spasticity with movement velocity, muscle reaction angle and quality.
measure of pain level through study completion, 14 months Pain type using a self-rating scale for estimating the likelihood of neuropathic painscale before treatment (named DN4), at 5 weeks, 3 months and endpoint using a 0 to 10 visual analogic scale
Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8) through study completion, 14 months Patient reported Experience Measures will be assessed at endpoint with the CSQ-8 questionnaire
Modified Ashworth scale through study completion, 14 months -Modified Ashworth scale, measures spasticity level according to a level scale (0,1,1+,2,3,4), 0=absence of muscle tone increase and 4=rigidity in flexion or extension of affected part(s)
Proportion of patients with antispastic drug through study completion, 14 months 10 meter walk test - distance through study completion, 14 months distance improvement assessed using the 6 minutes walking test (6MWT)
Evolution of Functional outcomes through study completion, 14 months Functional outcomes before treatment, at 5 weeks and 3 months using Goal Attainment Scaling primary outcome scoring
Evolution of ankle motion range through study completion, 14 months Active and/or passive ankle motion range Improvement at 5 weeks, 3 months and endpoint
Proportion of patients with adverse event through study completion, 14 months Adverse effects by systematic assessment at 5 weeks, 3 months and endpoint.
10 meter walk test - speed through study completion, 14 months Walking speed with the 10 meter walk test (10MWT)
Trial Locations
- Locations (4)
Hôpital Pierre Wertheimer
🇫🇷Bron, France
AP-HP
🇫🇷Clichy, France
CHU de Nantes
🇫🇷Nantes, France
Hôpital Henry Gabrielle
🇫🇷Saint-Genis-Laval, France