Imam Bita, Miller William C, Finlayson Heather C, Eng Janice J, Payne Michael Wc, Jarus Tal, Goldsmith Charles H, Mitchell Ian M
Graduate Program in Rehabilitation Sciences, University of British Columbia, Vancouver, BC, Canada.
JMIR Res Protoc. 2014 Dec 22;3(4):e80. doi: 10.2196/resprot.4031.
The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed "Wii.n.Walk", an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA.
The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group.
This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants' homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks' duration. The primary outcome measure will be the "Two-Minute Walk Test" to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up.
Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet.
Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs.
Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP).
因下肢截肢（LLA）而需要康复治疗以提高步行能力和活动能力的老年人数量正在增加。现有的康复治疗方法常常无法满足这一需求。任天堂Wii Fit可能是一种有助于进行康复干预的宝贵工具。基于试点研究，我们开发了“Wii.n.Walk”，这是一种针对LLA老年人提高步行能力的家庭远程医疗Wii Fit干预方案。
本研究的目的是确定与注意力控制组相比，Wii.n.Walk干预方案是否能提高步行能力。
本项目是一项多地点（不列颠哥伦比亚省温哥华市、安大略省伦敦市）、平行、评估者盲法随机对照试验。参与者包括年龄在50岁以上、单侧经胫骨或经股骨截肢的社区居住老年人。参与者将按地点分层，并以三人一组进行区组随机分组，分为Wii.n.Walk干预组或采用Wii大脑认知软件的注意力控制组。本试验将包括监督和非监督阶段。在监督阶段，两组每周将接受三次40分钟的监督小组训练，为期4周。参与者将在当地康复中心与一名训练师一起以三人一组的形式完成干预的第一周。其余3周将在参与者家中进行，由训练师使用苹果iPad技术进行远程监督。在4周结束时，监督期结束，非监督期开始。参与者将保留Wii游戏机，并被鼓励继续使用该程序另外4周。主要结局指标将是用于测量步行能力的“两分钟步行测试”。将在基线、监督和非监督阶段结束后以及1年随访后对所有参与者的结局指标进行评估。
两个地点都已聘请并培训了研究人员，目前正在进行招募。尚未招募到任何参与者。
Wii.n.Walk是一种很有前景的家庭远程医疗干预方案，对于从康复机构出院或居住在难以获得或无法获得现有康复项目的偏远地区的LLA老年人可能有实用价值。
Clinicaltrial.gov NCT01942798；http://clinicaltrials.gov/ct2/show/NCT01942798（由WebCite存档于http://www.webcitation.org/6V0w8baKP）。
