Upper-limb Active Function and Botulinum Toxin a

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Dec 18, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called botulinum toxin type A (BTX) on patients who have had a stroke and experience muscle stiffness or difficulty moving their arms. Specifically, the trial looks at how BTX injections into the muscles around the elbow can help improve movement by reducing unwanted muscle contractions when trying to extend the arm. This study is open to individuals who have had a stroke for at least six months and have trouble extending their elbow, but still have some ability to move it.

To participate, individuals must be over 18 years old and be willing to sign a consent form. They should not have other serious medical issues that could complicate the study. Participants can expect to receive BTX injections as part of their regular care, and the study will monitor their progress over time to see how well the treatment works. It's important to note that the treatment is intended to help improve arm movement and function, which can be valuable for daily activities and quality of life after a stroke.

Gender

ALL

Eligibility criteria

• Stroke group :
• 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.
• Exclusion Criteria:
• • 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.