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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 (FOOTNEUROTOX)

Primary Purpose

Post Stroke Seizure, Spastic Foot

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tibial nerve selective neurotomy
Botulinum toxin injection
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Stroke Seizure focused on measuring Tibial nerve selective neurotomy, botulinum toxin, spastic foot, post-stroke patient

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Hôpital Pierre Wertheimer
  • AP-HP
  • CHU de Nantes
  • Hôpital Henry Gabrielle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tibial nerve selective neurotomy

Botulinum toxin injection

Arm Description

Outcomes

Primary Outcome Measures

Evolution of the value of Goal Attainment Scaling
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

Evolution of Functional outcomes
Functional outcomes before treatment, at 5 weeks and 3 months using Goal Attainment Scaling primary outcome scoring
Tardieu's scale
Tardieu's scale assesses spasticity with movement velocity, muscle reaction angle and quality.
Modified Ashworth scale
-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)
Evolution of ankle motion range
Active and/or passive ankle motion range Improvement at 5 weeks, 3 months and endpoint
Proportion of patients with antispastic drug
measure of pain level
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
Proportion of patients with adverse event
Adverse effects by systematic assessment at 5 weeks, 3 months and endpoint.
Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8)
Patient reported Experience Measures will be assessed at endpoint with the CSQ-8 questionnaire
10 meter walk test - speed
Walking speed with the 10 meter walk test (10MWT)
10 meter walk test - distance
distance improvement assessed using the 6 minutes walking test (6MWT)

Full Information

First Posted
April 19, 2023
Last Updated
September 21, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05874154
Brief Title
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
Acronym
FOOTNEUROTOX
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Seizure, Spastic Foot
Keywords
Tibial nerve selective neurotomy, botulinum toxin, spastic foot, post-stroke patient

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tibial nerve selective neurotomy
Arm Type
Experimental
Arm Title
Botulinum toxin injection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Tibial nerve selective neurotomy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin injection
Intervention Description
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 for varus, and long flexor digitorum and flexor hallucis for claw toes), the appropriate dose and dilution based on his experience, following a semi-guided table of equivalence for respective doses of onabotulinumtoxin A and abobotulinumtoxin A. A delay superior to 3 months will be respected after the last injection and the muscles that have been defined pre-randomization will be targeted by injections.
Primary Outcome Measure Information:
Title
Evolution of the value of Goal Attainment Scaling
Description
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
Time Frame
through study completion, 14 months
Secondary Outcome Measure Information:
Title
Evolution of Functional outcomes
Description
Functional outcomes before treatment, at 5 weeks and 3 months using Goal Attainment Scaling primary outcome scoring
Time Frame
through study completion, 14 months
Title
Tardieu's scale
Description
Tardieu's scale assesses spasticity with movement velocity, muscle reaction angle and quality.
Time Frame
through study completion, 14 months
Title
Modified Ashworth scale
Description
-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)
Time Frame
through study completion, 14 months
Title
Evolution of ankle motion range
Description
Active and/or passive ankle motion range Improvement at 5 weeks, 3 months and endpoint
Time Frame
through study completion, 14 months
Title
Proportion of patients with antispastic drug
Time Frame
through study completion, 14 months
Title
measure of pain level
Description
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
Time Frame
through study completion, 14 months
Title
Proportion of patients with adverse event
Description
Adverse effects by systematic assessment at 5 weeks, 3 months and endpoint.
Time Frame
through study completion, 14 months
Title
Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8)
Description
Patient reported Experience Measures will be assessed at endpoint with the CSQ-8 questionnaire
Time Frame
through study completion, 14 months
Title
10 meter walk test - speed
Description
Walking speed with the 10 meter walk test (10MWT)
Time Frame
through study completion, 14 months
Title
10 meter walk test - distance
Description
distance improvement assessed using the 6 minutes walking test (6MWT)
Time Frame
through study completion, 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques LUAUTE, MD,PhD
Phone
04 72 35 71 69
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure CHARLOIS
Phone
0472355837
Email
anne-laure.charlois@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Pierre Wertheimer
City
Bron
ZIP/Postal Code
69394
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick MERTENS, MD,PhD
Facility Name
AP-HP
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pjilippe DECQ, MD,PhD
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin BUFFENOIR, MD,PhD
Facility Name
Hôpital Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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