Balance after Botox in the rectus femoris for stiff-knee gait
Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait: What About the Risk of Falls?
Hopital Nord Franche-Comte · NCT07108920
This test looks at whether Botox injections into the rectus femoris are linked to changes in balance and fall risk for people with stiff-knee gait after stroke, brain injury, or multiple sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hopital Nord Franche-Comte (other) |
| Locations | 1 site (Héricourt, Nord Franche-Comté) |
| Trial ID | NCT07108920 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with stiff-knee gait after stroke, cranial trauma, spinal cord lesion or multiple sclerosis who have rectus femoris spasticity ≥1, quadriceps strength ≥2/5, no botulinum toxin in the past three months, and stable anti-spastic medications.
Not a fit: Patients with unstable cardiac or respiratory disease, major cognitive impairment, recent knee trauma or surgery, significant coagulation disorders, or other conditions that prevent performing the required functional tests are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could help clinicians target rectus femoris injections to reduce balance problems and lower fall risk in people with stiff-knee gait.
How similar studies have performed: Previous studies applying botulinum toxin to the rectus femoris have shown promising improvements in knee swing and gait mechanics, but evidence directly linking these injections to better balance or fewer falls is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Héricourt, Nord Franche-Comté
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Botulinum Toxin Injection, Stiff Knee Gait, Fall Risk, Rectus Femoris Muscle, Botox Injection, Spasticity With Multiple Sclerosis, Botulinum toxin injection, Rectus femoris