Informations générales (source: ClinicalTrials.gov)
Upper-limb Active Function and Botulinum Toxin a (ULAFBoT-Stroke)
Interventional
N/A
University Hospital, Toulouse (Voir sur ClinicalTrials)
décembre 2020
décembre 2027
24 octobre 2024
This study in an observational, prospective and longitudinal study. The aim of the study
is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow
flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI)
during an active elbow extension in chronic post-stroke patients.TBA injections are
performed as part of routine care
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| University Hospital Toulouse - 31059 - Toulouse - France | David Gasq, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months;
- Indication to an injection of BTA in the elbow flexor muscles according to the usual
clinical criteria: request of elbow extension improvement with a functional or
aesthetic objective;
- Being under prescription of abobotulinum toxin A (DYSPORT®, Ipsen-Pharma);
- Ability of active elbow extension> 20 degrees;
- Limitation of active movement of elbow extension > 15 degrees or decreased or 50%
decrease in the active elbow extension rate;
- Patients who have never been treated with BTX or only a first injection that having
targeted the elbow flexors more than 4 months ago;
- Age> 18 years;
- Signature of informed consent;
- Subject affiliated to the social security coverture.
- Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months;
- Indication to an injection of BTA in the elbow flexor muscles according to the usual
clinical criteria: request of elbow extension improvement with a functional or
aesthetic objective;
- Being under prescription of abobotulinum toxin A (DYSPORT®, Ipsen-Pharma);
- Ability of active elbow extension> 20 degrees;
- Limitation of active movement of elbow extension > 15 degrees or decreased or 50%
decrease in the active elbow extension rate;
- Patients who have never been treated with BTX or only a first injection that having
targeted the elbow flexors more than 4 months ago;
- Age> 18 years;
- Signature of informed consent;
- Subject affiliated to the social security coverture.
- Passive limitation of elbow extension > 30 degrees;
- Pain during active movements of elbow flexion/extension;
- Cognitive disorder with limited comprehension of three basic instructions (like the
test of the 3 papers of the MMS);
- Evolutionary or decompensated neurological disease;
- Unstabilized epilepsy;
- Anticoagulant treatment with a curative dose or hemostasis disorder that
contraindicates intramuscular injections;
- Claustrophobia or metallic foreign bodies contraindicated for MRI;
- General contraindication for botulinum toxin injection: hypersensitivity to the
active substance or to one of the excipients, swallowing disorder, chronic
respiratory disorders, antecedent of myasthenia or Lambert Eaton syndrome;
antecedent of neuromuscular disease; surgery with curarization for less than a
month; current treatment with aminoglycoside, aminoquinoline, cyclosporine or
anticholinesterase.
- Presence of skin infection or inflammation at the injection site.
- Legal incapacity.
- Pregnant or breastfeeding woman;
- Woman with a desire to become pregnant within 18 months.
- Non-menopausal woman (a postmenopausal state is defined as no menses for 12 months
without an alternative medical cause) who does not use one of the following
contraceptive methods considered highly effective : intrauterine device,
oestroprogestonic contraception or progestogen hormonal contraception associated
with inhibition of ovulation, intrauterine hormone-releasing system, or bilateral
tubal occlusion.
Control group
- inclusion criteria:
- Age> 18 years
- Signature of informed consent.
- exclusion criteria:
- History of orthopedic or neurologic disorders;
- Subject expert in a sport intensively requiring the upper limbs (at least
departmental competition level);
- Legal incapacity.