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Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait

Recruitingn/aAges 18 Years - anyAllHopital Nord Franche-Comte
NCT07108920 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients who suffered a stroke, cranial traumatism, medullar lesions or multiple sclerosis can present spastic muscular complications, which is particularly impairing if it concerns muscles of the leg. Muscular spastic complications of the legs can alter significantly the ability to walk because it clinically manifests itself by a stiffness of the leg, thus generating a complication called "Stif Knee Gait" (SKG). It means that the femoro-patello-tibial articulation cannot be mobilized as it should because it stays spastic instead of being mobile. However, it remains possible to treat this kind of medical condition by using Botulinum toxin injections in the target muscle, in particular the rectus femoris (which is part of the quadriceps). As a reminder, botulinum toxin, sold under the international common denomination "Botox®", is a neurotoxin of 150 kDa produced by the bacteria "Clostr

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📋 Eligibility rules (as published)
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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What it tests

  • Functional clinical tests
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Where

1 site
Centre de Médecine Physique et de Réadaptation Bretegnier
Héricourt, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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