Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study
2021年10月7日 更新者：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).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
22
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 2G9
- GF Strong Rehabilitation Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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其他：SCOOT Delayed
This group will receive SCOOT after 6 weeks
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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.
Participants will begin the SCOOT intervention after a six week delay.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in scooter skills capacity
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wheelchair Skills Test for Scooters (WST-Sc)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Montreal Cognitive Assessment Test
大体时间：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)
大体时间：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.
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Baseline
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Hearing Handicap Inventory for the Elderly (HHIE) Screening version
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ben Mortenson、University of British Columbia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年3月1日
初级完成 (实际的)
2020年12月1日
研究完成 (实际的)
2021年10月1日
研究注册日期
首次提交
2016年2月23日
首先提交符合 QC 标准的
2016年2月25日
首次发布 (估计)
2016年3月2日
研究记录更新
最后更新发布 (实际的)
2021年10月11日
上次提交的符合 QC 标准的更新
2021年10月7日
最后验证
2021年10月1日
更多信息
与本研究相关的术语
其他研究编号
- H15-01921
- F15-00959 (其他赠款/资助编号：Canadian Institutes of Health Research)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.