Upper-limb Active Function and Botulinum Toxin a (NCT03783572) | Clinical Trial Compass
RecruitingNot Applicable
Upper-limb Active Function and Botulinum Toxin a
France80 participantsStarted 2020-12-08
Plain-language 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 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Measurement of the spastic co-contraction index from the EMG signal