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Towards Better Understanding of FCE Performance in Different Societal Contexts (FCEinternat)

22. juli 2015 opdateret af: Jan Kool, Klinik Valens

Purposes of this research:

  • To study similarities and differences in FCE performances between participants from different countries, jurisdictions, and evaluators.
  • To study determinants of FCE performance.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret beskrivelse

A considerable amount of research has been made on the safety, reliability and validity of the Functional Capacity Evaluation (FCE). Evidence is accumulating on different aspects of validity of FCE in healthy workers and in different patient groups, which has indicated that we are measuring a complex construct consisting of biological, psychological and social variables. However, this knowledge is still unstable as the majority of studies stem from a limited amount of countries. The present project focuses on the biopsychosocial factors that influence FCE performance. Participants undergoing an FCE perform differently depending on biological, psychological and social variables, although the latter has been under-researched. Clinicians are currently unable to predict which factors determine the differences in patient's FCE results. In this project, in addition to biological and psychological variables, investigators include a variety of social variables from different countries, jurisdictions, and evaluators, which may help investigators to identify important determinants of FCE performance. Knowing which characteristics and behaviors are associated with better or poorer participant performances may help clinicians to deliver improved FCE services.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

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

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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Persons with non-specific sub-acute or chronic musculoskeletal pain

Beskrivelse

Inclusion Criteria:

  • Musculoskeletal pain including: back pain, neck pain (including Whiplash-Associated Syndrome grade I or II), upper extremity pain, lower extremity pain.
  • Non-specific pain: without specific medical diagnosis, see also exclusion criteria) .
  • Complaints' duration > 6 weeks
  • Employed or self-employed
  • Language skills sufficient to communicate with the FCE-clinician and fill out the required questionnaires

Exclusion Criteria:

  • Pregnancy
  • Tumours
  • Fractures
  • Radicular syndromes
  • Spondylolisthesis grade 3 or 4)
  • Whiplash-Associated Syndrome grade III or IV
  • Other specific diagnoses related to the musculoskeletal System
  • Unstable cardiovascular conditions and other co-morbidity affecting performance or safety during the FCE (i.e. severe depression needing psychiatric referral).

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
Psychological factor: work related fear of movement (minimum 0 - maximum 10)
Tidsramme: one day (one measurement only, cross sectional study)
The fear avoidance beliefs questionnaire has been validated for this purpose
one day (one measurement only, cross sectional study)
Financial compensation in case of work related disability (% of previous income)
Tidsramme: one day (one measurement only, cross sectional study)
one day (one measurement only, cross sectional study)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Work related physical capacity: max weight safely lifted from floor to waist (kg)
Tidsramme: one day (one measurement only, cross sectional study)
This measure is reliable, safe and valid as it is related to physical work capacity.
one day (one measurement only, cross sectional study)
Work related physical capacity: distance walked in 6 minutes (meters)
Tidsramme: one day (one measurement only, cross sectional study)
This measure is reliable, safe and valid as it is related to physical work capacity.
one day (one measurement only, cross sectional study)
Work related physical capacity: grip strength (kg)
Tidsramme: one day (one measurement only, cross sectional study)
This measure is reliable, safe and valid as it is related to physical work capacity.
one day (one measurement only, cross sectional study)

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. august 2015

Primær færdiggørelse (Forventet)

1. august 2016

Studieafslutning (Forventet)

1. august 2017

Datoer for studieregistrering

Først indsendt

21. juli 2015

Først indsendt, der opfyldte QC-kriterier

22. juli 2015

Først opslået (Skøn)

24. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EKSG15/079

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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