Balance after Botox in the rectus femoris for stiff-knee gait

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, single-center project that follows adults with stiff-knee gait related to stroke, cranial trauma, spinal cord injury or multiple sclerosis who receive or have received botulinum toxin in the rectus femoris. Researchers use functional clinical tests and balance measures to document gait and fall-risk changes associated with the injection. Key inclusion criteria include at least four months since stroke when applicable, rectus femoris spasticity ≥1 on the modified Ashworth Scale, quadriceps strength ≥2/5, no botulinum toxin in the prior three months, and stable anti-spastic medication. The work takes place at the Centre de Médecine Physique et de Réadaptation Bretegnier in Héricourt, Nord Franche-Comté, France.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre de Médecine Physique et de Réadaptation Bretegnier
  Héricourt, Nord Franche-Comté, France Recruiting

Study contacts

• Study coordinator: Jean-Philippe JP Ehny, M.D
• Email: JPEHNY@fondation-arcenciel.fr
• Phone: +33 84 46 57 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.