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
NCT ID: NCT07260565
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-01
2028-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard rehabilitation protocol
Patients in this groupe will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.
standard rehabilitation programme
Patients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.
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.
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.
Interventions
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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.
standard rehabilitation programme
Patients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Clinique Victor Pauchet
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2025-A00591-48
Identifier Type: OTHER
Identifier Source: secondary_id
2025-A00591-48
Identifier Type: -
Identifier Source: org_study_id