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临床试验/NCT01837888
NCT01837888已完成不适用

A Feasibility Study to Evaluate and Refine a Manual Wheelchair Training Program That is Enhanced for Self-efficacy(WheelSee): A Pilot Controlled Trial

University of British Columbia2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Wheelchair-use Confidence Scale (WheelCon) Version 3.0 Change

研究概览

简要总结

Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if: 1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate; and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.

详细描述

The purpose of this study is to evaluate the feasibility of administering a novel self-efficacy enhanced wheelchair training intervention (WheelSee) for manual wheelchair users who are at least 19 years of age. Self-efficacy for wheelchair use is an important construct, which may influence wheelchair mobility and participation. Pilot data obtained from this study will inform the design of an experimental trial and refinement of the WheelSee intervention and protocol.

This study will use a randomized controlled, single blind design with a sample of 24 (12 intervention, 12 control). Participants will be randomly allocated to the intervention or control group using a computer generated table of random numbers. Participants allocated to the intervention group will take part in WheelSee in groups of 2-4. The WheelSee intervention consists of 6 (twice weekly, minimum 3 days apart) x 1.5 hour sessions. Participants will be encouraged to bring a family member to each session, who may act as a spotter during the practice of wheelchair skills. If no family member is available, a student volunteer spotter will be available to ensure a 1:1 spotter: wheelchair user ratio. All spotters will be trained in appropriate spotting techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years of age or older
  • Reside in the community
  • Daily use of a manual wheelchair (≥ 2 hours/day)
  • Able to self-propel (using any combination of hands or feet) a distance of 10 m
  • Would like to improve confidence using a manual wheelchair
  • Have wheelchair mobility goals
  • Able to read, write and speak at a Grade 8 English level
  • Score 25 or higher on the Mini Mental State Examination (MMSE)

排除标准

  • Have previously or are currently taking part in standardized wheelchair training
  • Are acutely ill

研究组 & 干预措施

Standard training provided by clinician

No Intervention

Participants in the control group will receive the current standard of care. (i.e., any training provided by the clinician or vendor who prescribes/provides the wheelchair). Participants will receive one follow up phone call to remind them of followup testing.

WheelSee Training Program

Experimental

Participants allocated to the intervention group will take part in WheelSee in groups of 2-4. The WheelSee intervention consists of 6 (twice weekly, minimum 3 days apart) x 1.5 hour sessions. Participants will be encouraged to bring a family member to each session, who may act as a spotter during the practice of wheelchair skills. If no family member is available, a student volunteer spotter will be available to ensure a 1:1 spotter: wheelchair user ratio. All spotters will be trained in appropriate spotting techniques.

干预措施: WheelSee Training Program (Device)

结局指标

主要结局

Wheelchair-use Confidence Scale (WheelCon) Version 3.0 Change

时间窗: Baseline; 5 weeks

Wheelchair-use Confidence Scale (WheelCon) Version 3.0 for manual wheelchair users is a 65-item self-report scale (0-100) with documented reliability and validity. Responses indicate current level of perceived confidence (%) to navigate the physical environment in a wheelchair, perform activities in a wheelchair, problem solve, advocate for specific needs, and manage social situations and emotions. The WheelCon was selected as the primary outcome measure because it is a standardized tool for evaluating confidence using a wheelchair, the primary construct of interest.

次要结局

  • Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q)(Baseline; 5 weeks)
  • Life-Space Assessment (LSA)(Baseline; 5 weeks)
  • The Wheelchair Outcome Measure (WhOM)(Baseline; 5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William C. Miller

Principal Investigator

University of British Columbia

研究点 (2)

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