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Botox for stiff legs: could it throw you off balance?

NCT ID NCT07108920

Knowledge-focused Sponsor: Hopital Nord Franche-Comte Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study looks at whether Botox injections in the thigh muscle (to treat stiff knee gait) affect a person's balance and risk of falling. Stiff knee gait can happen after a stroke, brain injury, or multiple sclerosis. The researchers will test balance before and after the injection using simple walking and standing tests. Only 15 people will take part, so the results will be very preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin (Botox)
What this could lead to
If this study finds no increased fall risk, it could reassure patients and doctors that Botox injections for stiff knee gait are safe regarding balance.
What could go wrong
This is a very small observational study (15 people) with no control group, so results may not apply to everyone. It only looks at short-term balance changes, not long-term safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The patients consists in patients suffering from a stiff knee gait (SKG) after a stroke, a post-traumatic cerebral lesion or a multiple sclerosis, and who never underwent any neurosurgical procedure and didn't ever change their anti-spastic treatments. Those patients will be seen only in hospital structure (readaptation center) and never outside (liberal practice).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient with a stif knee gait (SKG) after a stroke, a post-traumatic cerebral lesion or a multiple sclerosis. * If the patient had a stroke, it happened at least 4 month ago (before the inclusion). * The patient has a rectus femoris spasticity ≥ 1 on the modified Ashworth Scale with the hip in extension position. * A quadricipital muscular force ≥ 2/5 (MRC Scale) * The patient didn't receive any botulinum toxin injection during the 3 previous months * No modification of any anti-spastic medication during the inclusion in the actual month (Baclofène, Dantrolène). * No neurosurgical intervention or ligamentoplasty of the quadricipital ligament during the 6 previous months. * No recent knee traumatism with knee instability during the 6 previous weeks. Exclusion Criteria: * Other comorbidities invalidating the fonctionnal tests necessary for the study like : decompensated cardiac insufficiency, unstable respiratory insufficiency, coagulation troubles, neurocognitive impairments inhibiting the comprehension of isocinetical tests. * Patient without severe phasic trouble inhibiting the patient's ability to answer the evaluation scales. * Sensory lesions inhibiting the possibility to evaluate the walk : visual impairment, major proprioception impairment, or cerebellar ataxia. * Severe muscular deficit : genetic myopathy, psychomotric desadaptation syndrom * Absolute contraindication to botulinum toxin injections : urinary tract infection ; current treatment by aminoglycosidic antibiotics, severe myasthenia, urine retention in patient who can't receive a urinary catheter. * Patient with cognitive troubles compromitting the understanding and the realization of the study.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Botox injection Botulinum toxin injection Fall risk Rectus femoris muscle Spasticity with multiple sclerosis Stiff knee gait

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre de Médecine Physique et de Réadaptation Bretegnier

    RECRUITING

    Héricourt, Nord Franche-Comté, 70 400, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.