Self-Management for Amputee Rehabilitation Using Technology (SMART) Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Timed Up & Go Test (TUG)
研究概览
简要总结
The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with unilateral lower limb amputation (LLA). Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA. Our secondary hypothesis is that SMART can improve ambulation confidence, body function, depression, body image, pain, balance confidence, activities of daily living, satisfaction with life and habit formation for skin monitoring and prosthetic cleaning in individuals with LLA. A post-intervention one on one interview will be conducted to understand SMART acceptability. The entirety of the study, including intervention administration, assessment, and interviews will be conducted online.
详细描述
Participants will receive an online link to access the SMART platform. Online training on using the SMART platform will be provided for participants. Participants will be asked to complete one education module per week at their own convenience and weekly online meetings with a peer over the 6-week intervention period. The educational modules include psychological adaptation, residual limb management, nutrition/weight control, managing a prosthetic limb, managing chronic conditions and enhancing mobility. The modules include instructional movies, goal setting logs, and quizzes. A module can be stopped or "re-wound" at any point, and the participant's place and work-to-date is automatically saved. The SMART platform will be asynchronously monitored through a web portal by the trainer, who will be a PhD candidate in Rehabilitation Sciences and observe participant progress and provide feedback if required. If there is no online activity within a 7-day (consecutive) period, the trainer will contact the participant to inquire the reasons for inactivity and troubleshoot any problems including technical issues. Clinical outcomes measures will be collected at two timepoints (T1 & T2). A post-intervention one on one interview will be conducted to explore SMART acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults who are 19 years of age or older.
- •individuals who are post unilateral transtibial/transfemoral amputation and casted an initial prosthesis within the past year.
- •English speaking.
- •living in British Columbia or Ontario, Canada.
- •have access to an internet connectable device (e.g., computer or tablet)
排除标准
- •people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)
结局指标
主要结局
Timed Up & Go Test (TUG)
时间窗: 6 weeks
Functional assessment of walking capacity measured in seconds over 3 meters walkway
次要结局
- Ambulatory Self-Confidence Questionnaire (ASCQ)(6 weeks)
- The Center for Epidemiologic Studies Depression Scale (CES-D)(6 weeks)
研究者
William C. Miller
Principal Investigator
University of British Columbia