- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02696213
Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study
7 oktober 2021 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
British Columbia
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Vancouver, British Columbia, Kanada, V5Z 2G9
- GF Strong Rehabilitation Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: SCOOT Immediate
This group will receive SCOOT immediately
|
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.
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in scooter skills capacity
Tidsram: 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.
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Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Wheelchair Skills Test for Scooters (WST-Sc)
Tidsram: 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
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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)
Tidsram: 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.
|
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
Scooter Skills Confidence Questionnaire
Tidsram: 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
Tidsram: 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
|
Life Space Assessment (LSA) Questionnaire
Tidsram: 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
Tidsram: 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.
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Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Montreal Cognitive Assessment Test
Tidsram: Baseline
|
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)
Tidsram: 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
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Hearing Handicap Inventory for the Elderly (HHIE) Screening version
Tidsram: Baseline
|
The HHIE will be used to evaluate the participants' hearing abilities.
|
Baseline
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Scooter Physical Accessibility of Participant Home and Community
Tidsram: 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
Tidsram: Baseline
|
This task is used to measure the participants' visual attention and task switching abilities, which is related to on road driving
|
Baseline
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Snellen Eye Test
Tidsram: Baseline
|
Baseline
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ben Mortenson, University of British Columbia
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2016
Primärt slutförande (Faktisk)
1 december 2020
Avslutad studie (Faktisk)
1 oktober 2021
Studieregistreringsdatum
Först inskickad
23 februari 2016
Först inskickad som uppfyllde QC-kriterierna
25 februari 2016
Första postat (Uppskatta)
2 mars 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 oktober 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 oktober 2021
Senast verifierad
1 oktober 2021
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- H15-01921
- F15-00959 (Annat bidrag/finansieringsnummer: Canadian Institutes of Health Research)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .