Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)

Study Overview
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Brief Summary
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Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms. The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the early start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the late start of treatment group.

Official Title
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International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.

Conditions
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Post-stroke Arm Spasticity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent prior to data collection Hemiparesis and clinically relevant upper limb post-stroke spasticity Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC BoNT naïve or pre-treated with any BoNT product Exclusion Criteria: Recurrent stroke Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve<br>Subjects naïve to BoNT-A treatment. | |
| Botulinum toxin type A (BoNT-A) Pre-treated<br>Subjects pre-treated with BoNT-A. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics [SmPC]). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated). | Early and late start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A. Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF). | Final study visit: approximately 20 months after first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated). | Early and late start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A. Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF). | Approximately every 4 months starting from baseline up to 2 years |