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Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?

3. april 2016 opdateret af: Dr. Brenda Brouwer, Queen's University

Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?

Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The extent to which impairment (physical capacity) and function influence community reintegration is unclear. One of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level. Interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months. It has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration. This study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration. Stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals. Assessors will be blind to whether the subject is receiving a tune up. Evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

103

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University School of Rehabilitation Therapy
      • London, Ontario, Canada, N6G 1H1
        • School of Physical Therapy, University of Western Ontario

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

Beskrivelse

Inclusion Criteria:

  • first major unilateral hemispheric stroke,
  • english speaking,
  • adequate verbal communication,
  • discharged home or residential care

Exclusion Criteria:

  • serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
natural progression post-stroke
Eksperimentel: Intervention
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
Adfærdsmæssigt: physical rehabilitation
two weeks intensive physical rehabilitation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective Index of Physical and Social Outcome (SIPSO)
Tidsramme: baseline and 1 year
The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.
baseline and 1 year
Subjective Index of Social Integration (Subscale of SIPSO)
Tidsramme: baseline and one year
see Subjective Index of Physical and Social Outcome (SIPSO) above
baseline and one year
Subjective Index of Physical Integration (Subscale of SIPSO)
Tidsramme: baseline and one year
see 'Subjective Index of Physical and Social Outcome (SIPSO) above
baseline and one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mobility Function
Tidsramme: baseline and 1 year
Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)
baseline and 1 year
Physical Capacity
Tidsramme: baseline and 12 months
6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.
baseline and 12 months
Health-related Quality of Life - Physical
Tidsramme: baseline and one year
The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.
baseline and one year
Health-related Quality of Life - Mental
Tidsramme: baseline and one year
The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.
baseline and one year

Samarbejdspartnere og efterforskere

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

Sponsor

Queen's University

Samarbejdspartnere

Heart and Stroke Foundation of Ontario

Efterforskere

  • Ledende efterforsker: Brenda J Brouwer, PhD, Queen's University
  • Ledende efterforsker: Jayne Garland, Ph.D, Western University, Canada

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. december 2006

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

16. november 2006

Først indsendt, der opfyldte QC-kriterier

16. november 2006

Først opslået (Skøn)

17. november 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS SRA 5974

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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