- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02696213
Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study
7. oktober 2021 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
22
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 2G9
- GF Strong Rehabilitation Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: SCOOT Immediate
This group will receive SCOOT immediately
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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.
|
|
Annen: SCOOT Delayed
This group will receive SCOOT after 6 weeks
|
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.
Participants will begin the SCOOT intervention after a six week delay.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in scooter skills capacity
Tidsramme: Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year
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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.
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Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Wheelchair Skills Test for Scooters (WST-Sc)
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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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
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Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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Wheelchair Skills Test for Scooters - Questionnaire (WST-ScQ) (performance and confidence)
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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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.
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Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
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Scooter Skills Confidence Questionnaire
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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This measure evaluates the participant's confidence in managing their social environment
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Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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Wheeled Mobility Outcome Questionnaire
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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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).
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Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
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Life Space Assessment (LSA) Questionnaire
Tidsramme: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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The LSA measures participants' frequency and independence of mobility in increasingly larger life spaces over the past month.
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Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
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Scooter Use and Incidents
Tidsramme: Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year
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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.
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Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Montreal Cognitive Assessment Test
Tidsramme: Baseline
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This assessment is used to detect any mild cognitive impairments
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Baseline
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Late Life Functioning and Disability measure - Computer Assisted Testing (LLFDI - CAT)
Tidsramme: Baseline
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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.
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Baseline
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Hearing Handicap Inventory for the Elderly (HHIE) Screening version
Tidsramme: Baseline
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The HHIE will be used to evaluate the participants' hearing abilities.
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Baseline
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Scooter Physical Accessibility of Participant Home and Community
Tidsramme: Baseline
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This measure involves 14 yes/no questions inquiring about the accessibility of the participants' physical environment in their home and community.
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Baseline
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Trail Making B Test
Tidsramme: Baseline
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This task is used to measure the participants' visual attention and task switching abilities, which is related to on road driving
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Baseline
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Snellen Eye Test
Tidsramme: Baseline
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Baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ben Mortenson, University of British Columbia
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2016
Primær fullføring (Faktiske)
1. desember 2020
Studiet fullført (Faktiske)
1. oktober 2021
Datoer for studieregistrering
Først innsendt
23. februar 2016
Først innsendt som oppfylte QC-kriteriene
25. februar 2016
Først lagt ut (Anslag)
2. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- H15-01921
- F15-00959 (Annet stipend/finansieringsnummer: Canadian Institutes of Health Research)
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