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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02696213
Other study ID # H15-01921
Secondary ID F15-00959
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date October 2021

Study information

Verified date October 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Six Week Delay
Participants will begin the SCOOT intervention after a six week delay.

Locations

Country Name City State
Canada GF Strong Rehabilitation Center Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Montreal Cognitive Assessment Test This assessment is used to detect any mild cognitive impairments Baseline
Other Late Life Functioning and Disability measure - Computer Assisted Testing (LLFDI - CAT) 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
Other Hearing Handicap Inventory for the Elderly (HHIE) Screening version The HHIE will be used to evaluate the participants' hearing abilities. Baseline
Other Scooter Physical Accessibility of Participant Home and Community This measure involves 14 yes/no questions inquiring about the accessibility of the participants' physical environment in their home and community. Baseline
Other Trail Making B Test This task is used to measure the participants' visual attention and task switching abilities, which is related to on road driving Baseline
Other Snellen Eye Test Baseline
Primary Change in scooter skills capacity 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
Secondary Wheelchair Skills Test for Scooters (WST-Sc) 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
Secondary Wheelchair Skills Test for Scooters - Questionnaire (WST-ScQ) (performance and confidence) 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
Secondary Scooter Skills Confidence Questionnaire This measure evaluates the participant's confidence in managing their social environment Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
Secondary Wheeled Mobility Outcome Questionnaire 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
Secondary Life Space Assessment (LSA) Questionnaire 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
Secondary Scooter Use and Incidents 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