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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve | Subjects naïve to BoNT-A treatment. | ||
| Botulinum toxin type A (BoNT-A) Pre-treated | 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]). |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from post-stroke arm spasticity registered with Neurological clinics, Rehab centers with BoNT out-patient clinics and neurological practices.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hermagor | Austria | |||||
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| Approximately every 4 months starting from baseline up to 2 years |
| Bidart |
| France |
| Berlin | Germany |
| Zwolle | Netherlands |
| Bern | Switzerland |