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Trial record 1 of 1 for:    NCT02696213
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Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT02696213
Recruitment Status : Active, not recruiting
First Posted : March 2, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ben Mortenson, University of British Columbia

Brief 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).

Condition or disease Intervention/treatment Phase
Mobility Scooter Skills Training Other: Systematic, Comprehensive, One to One Training (SCOOT) Other: Six Week Delay Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Study Start Date : March 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: SCOOT Immediate
This group will receive SCOOT immediately
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.

SCOOT Delayed
This group will receive SCOOT after 6 weeks
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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).

  5. 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.

  6. 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.


Other Outcome Measures:
  1. Montreal Cognitive Assessment Test [ Time Frame: Baseline ]
    This assessment is used to detect any mild cognitive impairments

  2. 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.

  3. Hearing Handicap Inventory for the Elderly (HHIE) Screening version [ Time Frame: Baseline ]
    The HHIE will be used to evaluate the participants' hearing abilities.

  4. 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.

  5. 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

  6. Snellen Eye Test [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696213


Locations
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Canada, British Columbia
GF Strong Rehabilitation Center
Vancouver, British Columbia, Canada, V5Z 2G9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Ben Mortenson University of British Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ben Mortenson, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02696213    
Other Study ID Numbers: H15-01921
F15-00959 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019