Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Tilburg Frailty Indicator (TFI)
研究概览
简要总结
Elderly care has become one of the most important subjects in Taiwan and "frailty syndrome" are the most common problems among the elderly. In view of this trend, Taipei Veteran Memorial Hospital imported POWER rehabilitation from Japan in 2008. While showing significant clinical benefits, investigators have found that the system still has certain limitations (e.g. high cost, requires large space, patients must commute to the center, lacks real-time objective feedback , boring routines makes staying power to motivate patients for long term rehabilitation programs.)
To overcome the above limitations, this project proposes an evidence-based rehabilitation model that accounts for actual clinical need and collaborates with our engineering team to develop a "cluster" , "wearable" and "Brain-Computer Interface System" version of POWER rehabilitation system. Combining cloud technology, investigators now introduce internet-of-things into the POWER rehabilitation procedure. The result will lower the burden of clinical support personnel, and provide an opportunity to quantify "frailty syndromes" so as to allow objective and quantitative scientific evaluation, leading to a more objective clinical diagnosis.
In addition, this project further proposes a virtual-reality (VR) system for POWER rehabilitation, as well as designs for the VR sceneries. Through the use of different animated 3D VR sceneries and interactive game design, investigators can make rehabilitation interesting and fun for the patients, motivating long-term compliance of the patients, thereby, improving the clinical outcome of POWER rehabilitation.
This project has the potential to create an innovative solution to address the current bottlenecks of our rehabilitation treatment model. Successful development of the system will offer rehabilitation clinicians more treatment options, lower the cost of supporting staff, reduce commuting cost for the patients, and elevate patient desire to comply with the treatment program. Finally, the system will not only enhance Taiwan's academic reputation in the international arena, it will also generate new commercial opportunities for Taiwan and contribute to Taiwan economic development.
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
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60 to 85
- •Cardiovascular Health Study (CHS) frailty criteria
- •willing to sign agreement
排除标准
- •fracture w/o healing
- •severe joint injury
- •acute stroke or myocardial infarction (< 3 months)
- •cardiac arrhythmia / unstable blood pressure
- •disorientation or intellectual deterioration
- •muscle contracture deformity
- •pregnancy
结局指标
主要结局
Tilburg Frailty Indicator (TFI)
时间窗: Changes from baseline in physical examination at 12, 16 weeks
The TFI contains two parts, sociodemographic questions including questions on multimorbidity, lifestyle, life events and living environment (part A) and the assessment of components of frailty (part B). Frailty is assessed with 15 items divided into physical, social and psychological domains. All item scores are summed into a frailty score ranging from 0-15. Persons with a total TFI score ≧5 are considered to be frail.
次要结局
- visual test(Changes from baseline in physical examination at 12, 16 weeks)
- flexibility test_2nd (cm)(Changes from baseline in physical examination at 12, 16 weeks)
- general mobility test (sec)(Changes from baseline in physical examination at 12, 16 weeks)
- muscle endurance test (times/2 min)(Changes from baseline in physical examination at 12, 16 weeks)
- muscle strength test (kgw)(Changes from baseline in physical examination at 12, 16 weeks)
- hearing test (sec)(Changes from baseline in physical examination at 12, 16 weeks)
- Activity of daily living (ADL)(Changes from baseline in ADL at 12, 16 weeks)
- balance test (sec)(Changes from baseline in physical examination at 12, 16 weeks)
- flexibility test_1st (cm)(Changes from baseline in physical examination at 12, 16 weeks)
- hand-eye coordination test (sec)(Changes from baseline in physical examination at 12, 16 weeks)
- Instrumental Activities of Daily Living (IADL)(Changes from baseline in physical examination at 12, 16 weeks)
- Functional Independence Measure (FIM)(Changes from baseline in physical examination at 12, 16 weeks)
- 36-Item Short Form Health Survey (SF-36)(Changes from baseline in physical examination at 12, 16 weeks)