Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke (PSAS REGISTRY)
20. december 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
108
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2015
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
28. april 2015
Først indsendt, der opfyldte QC-kriterier
11. maj 2015
Først opslået (Skøn)
14. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A-38-52120-215
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Kliniske forsøg med Post Stroke Arm Spasticity
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Maisonneuve-Rosemont HospitalAfsluttetPost-tetanisk tæl på en arm, den anden arm er kontrollenCanada