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NCT Number: NCT07260565

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Isokinetic rehabilitation protocol.

Procedure

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

Procedure

Patients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.

Primary outcomes

  1. 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.

Secondary outcomes

  1. rPT values

    Time frame: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up

    rPT values

  2. 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

    Measured using an isokinetic dynamometer at different angular velocities.

  3. 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

    using the isokinetic dynamometer at different visits.

  4. 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

    using the Modified Aschworth Scale and stretch reflex measurement at different visits.

  5. 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 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.

  6. 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

    Using the Borg scale

  7. Clinical improvement in spasticity,

    Time frame: After 3 month follow-up and after 6 month follow-up

    which will be assessed by the doctor in charge of the patient

  8. 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

    Collect the number of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie DUSSAUSSOY, Clinical research associated

CONTACT

[email protected]

03 22 33 74 78

Sponsors and collaborators

Lead sponsor

Clinique Victor Pauchet

Other

Registry information

Acronym: ISOTOX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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