Status:
RECRUITING
Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait
Lead Sponsor:
Hopital Nord Franche-Comte
Conditions:
Botulinum Toxin Injection
Stiff Knee Gait
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07108920
Start Date
October 1 2025
End Date
August 1 2026
Last Update
September 22 2025
Active Locations (1)
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1
Centre de Médecine Physique et de Réadaptation Bretegnier
Héricourt, Nord Franche-Comté, France, 70 400