Upper-limb Active Function and Botulinum Toxin A (NCT03783572) | Clinical Trial Compass
TerminatedNot Applicable
Upper-limb Active Function and Botulinum Toxin A
Stopped: Difficulties in recruiting patients
France18 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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of the spastic co-contraction index from the EMG signal