- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696213
Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study
October 7, 2021 updated by: 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 2G9
- GF Strong Rehabilitation Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in scooter skills capacity
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheelchair Skills Test for Scooters (WST-Sc)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montreal Cognitive Assessment Test
Time Frame: Baseline
|
This assessment is used to detect any mild cognitive impairments
|
Baseline
|
Late Life Functioning and Disability measure - Computer Assisted Testing (LLFDI - CAT)
Time Frame: 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
Time Frame: Baseline
|
The HHIE will be used to evaluate the participants' hearing abilities.
|
Baseline
|
Scooter Physical Accessibility of Participant Home and Community
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ben Mortenson, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
February 25, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Actual)
October 11, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- H15-01921
- F15-00959 (Other Grant/Funding Number: Canadian Institutes of Health Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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