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Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study

7. oktober 2021 opdateret af: Ben Mortenson, University of British Columbia
Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel, community-based, client-centred intervention where skills training is incorporated into social activities that users want to perform. The trainer also offers problem solving strategies to help manage environmental barriers and to promote social participation. This intervention is different from customary scooter training in that customary training is often very limited and focuses on learning discrete skills outside of the user's normal environment. The purpose of this study is to explore the feasibility of conducting a mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which will evaluate the efficacy of SCOOT. We anticipate that the feasibility outcomes will be strong enough to support the conduct of a subsequent multi-site trial with a sufficient sample size to enable us to quantify definitive outcomes such as adverse events (e.g., injuries and abandonment).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • GF Strong Rehabilitation Center

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

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • English Speaking
  • Aged 60 or above
  • Has acquired a scooter in the last month prior to enrollment in the study

Exclusion Criteria:

  • Has a cognitive impairment that will prevent the individual from providing consent and reliably completing the study questionnaires
  • Reside in a nursing home
  • Plan to move outside Vancouver within the next year

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SCOOT Immediate
This group will receive SCOOT immediately
Andet: Systematic, Comprehensive, One to One Training (SCOOT)
An occupational therapist trained by the principal investigator will perform 1.5 hour SCOOT sessions with participants one to two times a week over a period of 6 weeks. SCOOT will provide instruction and practice for performing scooter skills (i.e., instruction on driving, basic and advanced scooter skills) that are embedded in self-selected activities that participants want to perform using their scooters.
Andet: SCOOT Delayed
This group will receive SCOOT after 6 weeks
Andet: Systematic, Comprehensive, One to One Training (SCOOT)
An occupational therapist trained by the principal investigator will perform 1.5 hour SCOOT sessions with participants one to two times a week over a period of 6 weeks. SCOOT will provide instruction and practice for performing scooter skills (i.e., instruction on driving, basic and advanced scooter skills) that are embedded in self-selected activities that participants want to perform using their scooters.
Andet: Six Week Delay
Participants will begin the SCOOT intervention after a six week delay.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in scooter skills capacity
Tidsramme: Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year
The WST-ScQ measures the participant's subjective scooter skills (capacity), and inquires on the frequency the skill is performed, and whether or not improvement of the skill is a personal goal.
Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wheelchair Skills Test for Scooters (WST-Sc)
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
The WST-Sc consists of 29 skills that are scored by an examiner from 0 to 2, where 0 = unsafe or unable, 1 = safe with difficulty, and 2 = safe without difficulty
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
Wheelchair Skills Test for Scooters - Questionnaire (WST-ScQ) (performance and confidence)
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
The WST-ScQ measures the participant's subjective scooter skills, and inquires on the participant's scooter skill confidence, frequency the skill is performed (performance), and whether or not improvement of the skill is a personal goal.
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
Scooter Skills Confidence Questionnaire
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
This measure evaluates the participant's confidence in managing their social environment
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
Wheeled Mobility Outcome Questionnaire
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
This measure evaluates indoor and outdoor participation levels associated with wheeled mobility provision by using an 11 point scale (0 = completely unsatisfied to 10 = completely satisfied).
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
Life Space Assessment (LSA) Questionnaire
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
The LSA measures participants' frequency and independence of mobility in increasingly larger life spaces over the past month.
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
Scooter Use and Incidents
Tidsramme: Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year
Participants will be asked to keep a diary of any scooter-related adverse events, including the following: tips or falls from the scooter, injuries to self, accidental contact with others, injuries to others, and damage to property. Participants will be asked to record the number of hours per day that they use their scooters.
Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Montreal Cognitive Assessment Test
Tidsramme: Baseline
This assessment is used to detect any mild cognitive impairments
Baseline
Late Life Functioning and Disability measure - Computer Assisted Testing (LLFDI - CAT)
Tidsramme: Baseline
The LLFDI-CAT is a computerized program that measures the participant's physical function. Drawing from a bank of 141 items, CAT continues until a standard error of 3 is obtained for the domain score, or a maximum of ten items has been administered.
Baseline
Hearing Handicap Inventory for the Elderly (HHIE) Screening version
Tidsramme: Baseline
The HHIE will be used to evaluate the participants' hearing abilities.
Baseline
Scooter Physical Accessibility of Participant Home and Community
Tidsramme: Baseline
This measure involves 14 yes/no questions inquiring about the accessibility of the participants' physical environment in their home and community.
Baseline
Trail Making B Test
Tidsramme: Baseline
This task is used to measure the participants' visual attention and task switching abilities, which is related to on road driving
Baseline
Snellen Eye Test
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

University of British Columbia

Efterforskere

  • Ledende efterforsker: Ben Mortenson, University of British Columbia

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 (Faktiske)

1. marts 2016

Primær færdiggørelse (Faktiske)

1. december 2020

Studieafslutning (Faktiske)

1. oktober 2021

Datoer for studieregistrering

Først indsendt

23. februar 2016

Først indsendt, der opfyldte QC-kriterier

25. februar 2016

Først opslået (Skøn)

2. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • H15-01921
  • F15-00959 (Andet bevillings-/finansieringsnummer: Canadian Institutes of Health Research)

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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