Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke (PSAS REGISTRY)
20. desember 2018 oppdatert av: Ipsen
Observational Prospective Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke, Under Conditions of Routine Clinical Practice
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
108
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ciecierzyn, Polen, 21-003
- Indywidualna Praktyka Lekarska
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Katowice, Polen, 40-752, ul Medyków 14
- Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego
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Sandomierz, Polen, 27-600 Schinzla 13
- Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym
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Szczecin, Polen, Chopina 22, 71-450
- Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii
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Warsaw, Polen, Sobieskiego 9, 02-957
- II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii
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Wrocław, Polen, 51-149 KOSZAROWA 5
- Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.
Beskrivelse
Inclusion Criteria:
- ≥ 18 years of age.
- A history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital.
- Post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified Ashworth scale - MAS ≥ 2) in at least one muscle group.
- Classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services.
- Drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation.
- Written informed consent given by patient before any occurrence of study related procedure.
- Patient has been already included in a NHF Dysport programme.
Exclusion Criteria:
- Severe dysphagia and respiratory disorders.
- Pregnancy
- Myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases).
- Generalized symptoms of infection
- The presence of inflammation within the planned sites of administration.
- Fixed contractures in the soft tissues and joints.
- Dementia medium or deep cycle (score on mini mental state examination (MMSE) equal to or less than 18 points).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)
Tidsramme: Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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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.
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Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Global assessment of spasticity by Modified Ashworth Scale (MAS)
Tidsramme: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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MAS - spasticity scores at each joint: shoulder, elbow, wrist, finger, thumb
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Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength
Tidsramme: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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To document cost of treatment with Dysport in these patients
Tidsramme: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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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.
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Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2015
Primær fullføring (Faktiske)
1. september 2016
Studiet fullført (Faktiske)
1. september 2016
Datoer for studieregistrering
Først innsendt
28. april 2015
Først innsendt som oppfylte QC-kriteriene
11. mai 2015
Først lagt ut (Anslag)
14. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A-38-52120-215
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Kliniske studier på Post Stroke Arm Spasticity
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Maisonneuve-Rosemont HospitalFullførtPost-tetanisk telling på en arm, den andre armen er kontrollenCanada