Partial Blocks of Rectus Femoris and Soleus With Botulinum Toxin Type A (Xeomin®) to Improve Gait in Hemiparesis (GENUFLEX)
Hemiparesis After Stroke, Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Hemiparesis After Stroke focused on measuring Muscle spasticity, Botulinum toxin
Eligibility Criteria
Inclusion Criteria
- Hemiparesis from stroke, brain trauma, or non evolutive brain tumor >6 months before enrolment
- Hip flexion at swing phase on the paretic side clinically insufficient (rated <15° by the clinical investigator)
- Passive ankle dorsiflexion clinically insufficient at late stance (rated <90° by the clinical investigator)
- Maximal ambulation speed barefoot over 10 metres < 1,3 m/sec
- Age ≥ 18
- Signed consent form
Exclusion Criteria
- Ambulation impossible barefoot
- Passive hip flexion amplitude (with the knee flexed) < 45° on paretic side
- Severe intercurrent disease ou cognitive dysfunction making effective communication or study participation impossible.
- Current anticoagulation with INR> 3,5 ; less than 15 days prior to D1
- Pregnancy, lactation, or premenopause woman not taking contraception
- Hypersensitivity to botulinum toxin or its excipients, myasthenia gravis, Lambert-Eaton syndrome, concomitant aminoside treatment.
- Infection or inflammation at injection sites.
- Injection in lower limb less than 3 months prior to D1
- Person not covered by social security
Sites / Locations
- Henri Mondor HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
Group 1
Group 2
Group 3
Placebo in soleus and placebo in rectus femoris, and placebo in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.
Botulinum toxin type A in soleus and placebo in rectus femoris, and Botulinum toxin type A in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.
Botulinum toxin type A in soleus and in rectus femoris, and Botulinum toxin type A in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.