Status:
RECRUITING
Upper-limb Active Function and Botulinum Toxin a
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Stroke
Muscle Spasticity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
BTX is a valuable treatment in the management of the focal muscle overactivity (spasticity) following acquired brain injury. If BTX injections reduce spasticity, few studies have examined its effect o...
Eligibility Criteria
Inclusion
- Stroke group :
- 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
- 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.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03783572
Start Date
December 8 2020
End Date
December 30 2027
Last Update
October 23 2024
Active Locations (1)
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1
University Hospital Toulouse
Toulouse, France, 31059