Post Stroke SeizureFOOTNEUROTOXNCT05874154
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
A study testing Tibial nerve selective neurotomy and Botulinum toxin injection in people with Post Stroke Seizure and Spastic Foot, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post Stroke Seizure, Spastic Foot
- What is being tested?
- Tibial nerve selective neurotomy and Botulinum toxin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Jan 2024to 2 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Hôpital Pierre Wertheimer
Bron, 69394
Patrick MERTENS, MD,PhD
- Not yet recruiting
AP-HP
Clichy, 92110
Pjilippe ² DECQ, MD,PhD
- Not yet recruiting
CHU de Nantes
Nantes, 44093
Kevin BUFFENOIR, MD,PhD
- Recruiting
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Jacques LUAUTE, MD,PhD
About this study
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.
- Conditions
- Post Stroke Seizure, Spastic Foot
- Being tested
- Tibial nerve selective neurotomy, Botulinum toxin injection
- Keywords
- Tibial nerve selective neurotomy, botulinum toxin, spastic foot, post-stroke patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial nerve selective neurotomyProcedure or surgery
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.
Botulinum toxin injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tibial nerve selective neurotomy | Experimental | Not described Receives: Procedure: Tibial nerve selective neurotomy |
| Botulinum toxin injection | Active comparator | Not described Receives: Drug: Botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, 14 months
Secondary outcomes (10)
Evolution of Functional outcomes
Functional outcomes before treatment, at 5 weeks using Goal Attainment Scaling primary outcome scoring
Measured: through study completion, 14 months
Tardieu's scale
Tardieu's scale assesses spasticity with movement velocity, muscle reaction angle and quality.
Measured: through study completion, 14 months
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)
Measured: through study completion, 14 months
Evolution of ankle motion range
Active and/or passive ankle motion range Improvement at 5 weeks and endpoint
Measured: through study completion, 14 months
Proportion of patients with antispastic drug
Measured: through study completion, 14 months
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 and endpoint using a 0 to 10 visual analogic scale
Measured: through study completion, 14 months
Proportion of patients with adverse event
Adverse effects by systematic assessment at 5 weeks and endpoint.
Measured: through study completion, 14 months
Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8)
Patient reported Experience Measures will be assessed at endpoint with the CSQ-8 questionnaire
Measured: through study completion, 14 months
10 meter walk test - speed
Walking speed with the 10 meter walk test (10MWT)
Measured: through study completion, 14 months
10 meter walk test - distance
distance improvement assessed using the 6 minutes walking test (6MWT)
Measured: through study completion, 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start2 Jan 2024
- Primary completion2 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke SeizureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874154
- Sponsor's protocol ID
- 69HCL22_0905
- Acronym
- FOOTNEUROTOX
- Status last verified
- Jul 2025
- First submitted
- 19 Apr 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05874154
- Acronym / sponsor ID
- FOOTNEUROTOX / 69HCL22_0905
- Conditions
- Post Stroke Seizure, Spastic Foot
- Keywords
- Tibial nerve selective neurotomy, botulinum toxin, spastic foot, post-stroke patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibial nerve selective neurotomy | Experimental | Procedure: Tibial nerve selective neurotomy |
| Botulinum toxin injection | Active comparator | Drug: Botulinum toxin injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibial nerve selective neurotomyPatients 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. | Procedure or surgery | Tibial nerve selective neurotomy |
| Botulinum toxin injectionPatients 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. | Drug | Botulinum toxin injection |
Primary outcome
Evolution of the value of Goal Attainment Scaling
Time frame: 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
10 secondary outcomes
Evolution of Functional outcomes
Time frame: through study completion, 14 months
Tardieu's scale
Time frame: through study completion, 14 months
Modified Ashworth scale
Time frame: through study completion, 14 months
Evolution of ankle motion range
Time frame: through study completion, 14 months
Proportion of patients with antispastic drug
Time frame: through study completion, 14 months
measure of pain level
Time frame: through study completion, 14 months
Proportion of patients with adverse event
Time frame: through study completion, 14 months
Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8)
Time frame: through study completion, 14 months
10 meter walk test - speed
Time frame: through study completion, 14 months
10 meter walk test - distance
Time frame: through study completion, 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial nerve selective neurotomy and Botulinum toxin injection in people with Post Stroke Seizure and Spastic Foot, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques LUAUTE, MD,PhD (04 72 35 71 69, jacques.luaute@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the value of Goal Attainment Scaling (time frame: through study completion, 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.