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Sunnaas International Network´s Stroke Study (SINs)

24. april 2017 opdateret af: Birgitta Langhammer, Sunnaas Rehabilitation Hospital

A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.

A descriptive study of the stroke rehabilitation content in specialized clinics in seven countries: procedures for admission to rehabilitation, services available and provided to patients, as well as duration of the stay and discharge routines. An observational study of changes in regard to the physical function, quality of life and psycho-social factors in stroke patients before and after specialized rehabilitation

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The descriptive study is two folded:

1) Description of the rehabilitation centers and the content the respective clinic presents as specialized rehabilitation.

A description of the expected change this input will result in in form of patients change in ADL and life satisfaction, with repeated measurements:

2a) reports of change in activities of daily living from baseline, to one fixed time (18-22 days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively fixed time) .

2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months after discharge.

Since the times for admission is expected to vary, which will be described under 1),we also want to measure if and how this difference might influence results. Therefore a fixed measure is inserted between admission and discharge. we have added a "relatively" fixed date at 6 months post stroke in order to see if change of function from specialized rehabilitation will differ in a longitudinal perspective, and if possible to see if the difference in time to admission (time from debut till admission in specialized rehabilitation)might influence results.

3) description of psycho- social factors at 6 and 12 months post discharge

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

230

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Petrozavodsk, Den Russiske Føderation
        • Petrozavodsk
  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater
        • Rusk Institute
  • Israel
      • Tel Aviv, Israel
        • Sheba Medical Center
  • Kina
      • Beijing, Kina
        • China Research rehabilitation center
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Sichuan 81 rehabilitation center
  • Norge
      • Nesoddtangen, Norge
        • Sunnaas rehabilitation hospital
  • Palæstinensisk territorium, besat
      • Gaza, Palæstinensisk territorium, besat
        • El Wafa rehabilitation center
    • Palestine
      • Betlehem, Palestine, Palæstinensisk territorium, besat
        • Betlehem arab society rehabilitation
  • Sverige
      • Gothenburgh, Sverige
        • Sahlgrenska University Hospital

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

stroke patients in need of specialised comprehensive rehabilitation

Beskrivelse

Inclusion Criteria:

  • primary diagnosis of stroke, in need of specialized comprehensive rehabilitation, voluntary participation

Exclusion Criteria:

  • sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with stroke that will influence outcomes

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
stroke patients
specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
Andet: rehabilitation
Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge
Andre navne:
  • multidisciplinary specialised rehabilitation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
activities of daily living
Tidsramme: patients will be followed 6 months from baseline testing
Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.
patients will be followed 6 months from baseline testing

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Life Satisfaction checklist (LiSat-11)
Tidsramme: patients will be followed 6 months from baseline testing
LiSat-11 consists of patients estimations of satisfaction with life as a whole as well as satisfaction in ten specific domains: vocation, economy, leisure, contacts, sexual life, activities of daily living (ADL), family life, partner relationship, somatic health, psychological health
patients will be followed 6 months from baseline testing

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
National Institutes of health stroke scale (NIHSS)
Tidsramme: patients will be tested baseline and at discharge

NIHSS is a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients.

The timeframe for discharge will vary with the different clinics since this is one of the differences expected.

Length of stay is one of the outcomes
patients will be tested baseline and at discharge
Modified Rankin Scale
Tidsramme: patients will be followed 6 months from baseline testing
it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke
patients will be followed 6 months from baseline testing
Description of the psycho- social situation
Tidsramme: 6 months after discharge
A semi - structured interview, with focus on the psycho-social situation 6 months after rehabilitation, will be performed. Questions will focus on the work-, financial situation, what sort of follow-up services, recreational- and social activities are available, and what is considered the major change of life after stroke.
6 months after discharge
description of institution
Tidsramme: baseline
a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge
baseline
registration data
Tidsramme: baseline
questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunnaas Rehabilitation Hospital

Samarbejdspartnere

Sahlgrenska University Hospital, Sweden
Sheba Medical Center
China Rehabilitation Research Center
Sichuan 81 Rehabilitation Center, Chengdu
NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York
City outpatient clinics №2,Petrozavodsk, Petrozavodsk
Al-Wafa Rehabilitation Hospital
Bethlehem Arab Society for Rehabilitation, Betlehem

Efterforskere

  • Studieleder: Johan K Stanghelle, PhD, MD, Sunnaas Rehabilitation Hospital, University of Oslo

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. september 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

8. november 2012

Først indsendt, der opfyldte QC-kriterier

23. november 2012

Først opslået (Skøn)

26. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SINs stroke study

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Sponsorer og samarbejdspartnere

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Betingelser

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Placeringer

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