Giesbrecht Edward M, Miller William C, Eng Janice J, Mitchell Ian M, Woodgate Roberta L, Goldsmith Charles H
Department of Occupational Science and Occupational Therapy, University of British Columbia, Vancouver, Canada.
Trials. 2013 Oct 24;14:350. doi: 10.1186/1745-6215-14-350.
Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial.
A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life.
The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses.
Clinical Trials NCT01740635.
许多老年人依靠手动轮椅出行，但通常很少接受关于如何有效且独立使用轮椅的培训，即便有培训也非常少。标准化技能培训是一种有效的干预措施，但临床培训师数量有限是一个实质性障碍。通过提高轮椅技能增强社区参与度（EPIC Wheels）是一项为期1个月的居家监测培训项目，旨在提高老年新手手动轮椅使用者的出行技能，该项目整合了成人教育学和社会认知理论的原则。本研究的目的是确定EPIC Wheels项目的可行性指标和主要临床结局指标是否足够可靠，以证明开展后续多中心随机对照试验的合理性。
在两个地点进行一项2×2析因随机对照试验，比较EPIC Wheels治疗组和电脑游戏对照组在轮椅出行技能方面的改善情况，并将额外引入轮椅使用作为第二个因素。将招募至少55岁、居住在加拿大两个大城市（n = 20×2）的40名社区居家手动轮椅使用者。在数据收集期间和研究期结束时，将收集与研究过程、资源、管理和治疗问题相关的可行性指标，并根据提议的标准进行评估。临床结局指标将在基线（随机分组前）和干预后收集。主要临床结局指标是轮椅技能能力，由轮椅技能测试第4.1版确定。次要临床结局指标包括轮椅技能安全性、对表现的满意度、轮椅信心、生活空间移动性、注意力分散情况以及与健康相关的生活质量。
EPIC Wheels培训项目具有几个创新特点。基于平板电脑的便捷、便携、经济且适应性强的居家项目模式用于轮椅技能培训，在临床应用方面具有巨大潜力，并且有未来改进的机会。理论驱动的设计可以促进老年人的学习和坚持。确定研究方案的可行性并估计主要临床结局指标的效应大小，将用于开展多中心随机对照试验以检验指导假设。
临床试验编号NCT01740635。
