Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT07108920
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07108920
Study Brief:
Protocol Section:
NCT07108920