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The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to collect data in patients scheduled to receive Dysport treatment in a drug programme, based on routine treatment of subject with ULS.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I) | Clinical Global Impression of Improvement (CGI-I) scale: 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change. | Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation) |
| Measure | Description | Time Frame |
|---|---|---|
| Global assessment of spasticity by Modified Ashworth Scale (MAS) | MAS - spasticity scores at each joint: shoulder, elbow, wrist, finger, thumb | Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation) |
| Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indywidualna Praktyka lekarska | Ciecierzyn | 21-003 | Poland | |||
| Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego |
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| Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation) |
| To document cost of treatment with Dysport in these patients | Direct costs associated with the administration of Dysport will include the dose of Dysport, interval between reinjections, cost of healthcare resources: needles, syringes, identification techniques of the muscles. | Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation) |
| Katowice |
| 40-752, ul Medyków 14 |
| Poland |
| Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym | Sandomierz | 27-600 Schinzla 13 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii | Szczecin | Chopina 22, 71-450 | Poland |
| II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii | Warsaw | Sobieskiego 9, 02-957 | Poland |
| Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego | Wroclaw | 51-149 KOSZAROWA 5 | Poland |