Spasticity of the Plantar FlexorsISOTOXNCT07260565
Impact of a Sequential Isokinetic Fatigue Protocol Followed by Ankle Strengthening After Botulinum Toxin Injection Into Spastic Plantar Flexors on Foot Lift Strength and Walking
A study testing Isokinetic rehabilitation protocol. and standard rehabilitation programme in people with Spasticity of the Plantar Flexors, run by Clinique Victor Pauchet.
Trial summary
Spastic foot drop (speed- and force-dependent hypertonia) is one of the most common neuro-orthopaedic disorders following brain injury. It has a negative impact on walking and is closely linked to independence in activities of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity of the Plantar Flexors
- What is being tested?
- Isokinetic rehabilitation protocol. and standard rehabilitation programme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Nov 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Patient with spastic hemiplegia (regardless of cause)
- MAS 1-2 spasticity of the plantar flexors
- Deficit of the foot lifters at the minimum stage of contraction with movement
- Patient who has received botulinum toxin injections in the plantar flexors
- Patient who has been informed about the research and has given their written and signed informed consent
- Patient affiliated with a social security scheme or beneficiary of such a scheme
Who cannot join
- Refusal of consent
- Patient with severe cognitive impairment (MMSE <23/30)
- Surgery on the affected lower limb
- Patient unable to read, write or understand French
- Patient who is pregnant or breastfeeding, in accordance with Article L1121-5 of the CSP
- Vulnerable patients according to Article L1121-6 of the CSP
- Adult patients under guardianship, curatorship or judicial protection
- Patients unable to give their consent in person according to Article L.1121-8 of the CSP or adults protected by law
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aurélie DUSSAUSSOY, Clinical research associated contact
About this study
Spastic foot drop (speed- and force-dependent hypertonia) is one of the most common neuro-orthopaedic disorders following brain injury. It has a negative impact on walking and is closely linked to independence in activities of daily living.
This disorder combines a deficit in muscle strength in the plantar flexors and extensors with pathological hypertonia of the plantar flexors, causing an imbalance in ankle flexion and resulting in equinus deformity of the foot.
Read more
Botulinum toxin is the first-line pharmacological treatment for focal spasticity of neurological origin, and its effectiveness is directly linked to the quality and quantity of associated rehabilitation care. However, the associated rehabilitation protocols remain vague and are based on general recommendations combining: stretching of muscles and tendons, muscle strengthening of spastic muscles, their agonists and antagonists, and functional work. The standard rehabilitation protocol used in our centre will be detailed in the study protocol.
The isokinetic dynamometer is an open-chain muscle strengthening tool that has the advantage of introducing a concept of reproducible assessment and rehabilitation.
This reproducibility is difficult to guarantee with the rehabilitation techniques practised by a therapist, whose applied force and precision may vary from one session to another. We have therefore developed a sequential muscle strengthening protocol combining strengthening work - fatigue of the triceps surae followed by muscle strengthening work of the foot lifters.
The aim of this work is to determine the effects of this protocol compared to conventional rehabilitation aimed at promoting the post-injection effects of botulinum toxin.
- Conditions
- Spasticity of the Plantar Flexors
- Being tested
- Isokinetic rehabilitation protocol., standard rehabilitation programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic rehabilitation protocol.Procedure or surgery
Patients in group will undergo isokinetic rehabilitation therapy five times a week, Monday to Friday, combining physiotherapy, adapted physical activity (see standard rehabilitation protocol) and strengthening exercises on an isokinetic dynamometer.
standard rehabilitation programmeProcedure or surgery
Patients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.
| Study group | Role | What they receive |
|---|---|---|
| standard rehabilitation protocol | Other | Patients in this groupe will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity. Receives: Procedure: standard rehabilitation programme |
| isokinetic rehabilitation protocol | Experimental | Patients in this group will undergo isokinetic rehabilitation five times a week, Monday to Friday, and will receive treatment combining physiotherapy, adapted physical activity (see standard rehabilitation protocol) and strengthening on an isokinetic dynamometer. Receives: Procedure: Isokinetic rehabilitation protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of the foot lifters
The strength of the foot lifters will be assessed by the maximum peak torque of the foot lifters at 60° (rPT 60°) measured using an isokinetic dynamometer. The primary endpoint is the change in rPT 60° between the value at inclusion and the value at the end of rehabilitation. This endpoint will be compared between the two arms.
Measured: At the baseline, and after 1 month of rehabilitation course
Secondary outcomes (8)
rPT values
rPT values
Measured: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
Peak torque resistance
Measured using an isokinetic dynamometer at different angular velocities.
Measured: At the baseline, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
Measurement of the agonist/antagonist ratio
using the isokinetic dynamometer at different visits.
Measured: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
The spasticity score measured
using the Modified Aschworth Scale and stretch reflex measurement at different visits.
Measured: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection , after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
The distance covered during a 6-minute walk test and the walking speed measured during a 10-metre walk test at the various follow-up visits.
The distance covered during a 6-minute walk test and the walking speed measured during a 10-metre walk test at the various follow-up visits.
Measured: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
The exercise tolerance score
Using the Borg scale
Measured: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
Clinical improvement in spasticity,
which will be assessed by the doctor in charge of the patient
Measured: After 3 month follow-up and after 6 month follow-up
Collect the number of adverse events
Collect the number of adverse events
Measured: At the baseline, before the rehabilitation protocol, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity of the Plantar FlexorsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Victor Pauchet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260565
- Sponsor's protocol ID
- 2025-A00591-48
- Other IDs
- 2025-A00591-48
- Acronym
- ISOTOX
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Sequential Isokinetic Fatigue Protocol Followed by Ankle Strengthening After Botulinum Toxin Injection Into Spastic Plantar Flexors on Foot Lift Strength and Walking
- ClinicalTrials.gov ID
- NCT07260565
- Acronym / sponsor ID
- ISOTOX / 2025-A00591-48
- Conditions
- Spasticity of the Plantar Flexors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clinique Victor PauchetUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Dec 2025 (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.
Spastic foot drop (speed- and force-dependent hypertonia) is one of the most common neuro-orthopaedic disorders following brain injury. It has a negative impact on walking and is closely linked to independence in activities of daily living.
This disorder combines a deficit in muscle strength in the plantar flexors and extensors with pathological hypertonia of the plantar flexors, causing an imbalance in ankle flexion and resulting in equinus deformity of the foot.
Botulinum toxin is the first-line pharmacological treatment for focal spasticity of neurological origin, and its effectiveness is directly linked to the quality and quantity of associated rehabilitation care. However, the associated rehabilitation protocols remain vague and are based on general recommendations combining: stretching of muscles and tendons, muscle strengthening of spastic muscles, their agonists and antagonists, and functional work. The standard rehabilitation protocol used in our centre will be detailed in the study protocol.
The isokinetic dynamometer is an open-chain muscle strengthening tool that has the advantage of introducing a concept of reproducible assessment and rehabilitation.
This reproducibility is difficult to guarantee with the rehabilitation techniques practised by a therapist, whose applied force and precision may vary from one session to another. We have therefore developed a sequential muscle strengthening protocol combining strengthening work - fatigue of the triceps surae followed by muscle strengthening work of the foot lifters.
The aim of this work is to determine the effects of this protocol compared to conventional rehabilitation aimed at promoting the post-injection effects of botulinum toxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard rehabilitation protocol | Other | Procedure: standard rehabilitation programmePatients in this groupe will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity. |
| isokinetic rehabilitation protocol | Experimental | Procedure: Isokinetic rehabilitation protocol.Patients in this group will undergo isokinetic rehabilitation five times a week, Monday to Friday, and will receive treatment combining physiotherapy, adapted physical activity (see standard rehabilitation protocol) and strengthening on an isokinetic dynamometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient
- Patient with spastic hemiplegia (regardless of cause)
- MAS 1-2 spasticity of the plantar flexors
- Deficit of the foot lifters at the minimum stage of contraction with movement
- Patient who has received botulinum toxin injections in the plantar flexors
Key exclusion criteria (8 listed)
- Refusal of consent
- Patient with severe cognitive impairment (MMSE <23/30)
- Surgery on the affected lower limb
- Patient unable to read, write or understand French
- Patient who is pregnant or breastfeeding, in accordance with Article L1121-5 of the CSP
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 |
|---|---|---|
| Isokinetic rehabilitation protocol.Patients in group will undergo isokinetic rehabilitation therapy five times a week, Monday to Friday, combining physiotherapy, adapted physical activity (see standard rehabilitation protocol) and strengthening exercises on an isokinetic dynamometer. | Procedure or surgery | isokinetic rehabilitation protocol |
| standard rehabilitation programmePatients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity. | Procedure or surgery | standard rehabilitation protocol |
Primary outcome
Strength of the foot lifters
Time frame: At the baseline, and after 1 month of rehabilitation course
The strength of the foot lifters will be assessed by the maximum peak torque of the foot lifters at 60° (rPT 60°) measured using an isokinetic dynamometer. The primary endpoint is the change in rPT 60° between the value at inclusion and the value at the end of rehabilitation. This endpoint will be compared between the two arms.
8 secondary outcomes
rPT values
Time frame: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
Peak torque resistance
Time frame: At the baseline, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
Measurement of the agonist/antagonist ratio
Time frame: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
The spasticity score measured
Time frame: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection , after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
The distance covered during a 6-minute walk test and the walking speed measured during a 10-metre walk test at the various follow-up visits.
Time frame: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
The exercise tolerance score
Time frame: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
Clinical improvement in spasticity,
Time frame: After 3 month follow-up and after 6 month follow-up
Collect the number of adverse events
Time frame: At the baseline, before the rehabilitation protocol, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Spasticity of the Plantar Flexors
Not yet recruiting
Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity
Stroke, Post-stroke Spasticity of the Lower Limb
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.
Aurélie DUSSAUSSOY, Clinical research associated contact
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic rehabilitation protocol. and standard rehabilitation programme in people with Spasticity of the Plantar Flexors, run by Clinique Victor Pauchet.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Aurélie DUSSAUSSOY, Clinical research associated (03 22 33 74 78, aurelie.dussaussoy@pauchet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength of the foot lifters (time frame: At the baseline, and after 1 month of rehabilitation course). 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 17 Dec 2025.