Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment

Study Overview
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Brief Summary
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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.

Conditions
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Frailty Syndrome, Intelligent POWER Rehabilitation Cluster Machine

Intervention / Treatment
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* Device: Intelligent POWER Rehabilitation Cluster Machine
* Other: general physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 60 to 85 Cardiovascular Health Study (CHS) frailty criteria willing to sign agreement Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional rehabilitation<br>Each subject will do traditional rehabilitation work two times per week and one hour at a time , lasting 24 weeks. | Other: general physical therapy<br> <br> |
| Experimental: Power rehabilitation<br>Each subject will do Power rehabilitation work with motion tracking and biofeedback recording two times per week and one hour at a time, lasting 24 weeks. | Device: Intelligent POWER Rehabilitation Cluster Machine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tilburg Frailty Indicator (TFI) | 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. | Changes from baseline in physical examination at 12, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| balance test (sec) | single leg stance with eyes open | Changes from baseline in physical examination at 12, 16 weeks | 
| flexibility test_1st (cm) | truck flexion test in standing position | Changes from baseline in physical examination at 12, 16 weeks | 
| flexibility test_2nd (cm) | truck flexion test in sitting position | Changes from baseline in physical examination at 12, 16 weeks | 
| general mobility test (sec) | timed up and go test | Changes from baseline in physical examination at 12, 16 weeks | 
| hand-eye coordination test (sec) | grasp an falling rod | Changes from baseline in physical examination at 12, 16 weeks | 
| muscle endurance test (times/2 min) | step in place with hip raising to level | Changes from baseline in physical examination at 12, 16 weeks | 
| muscle strength test (kgw) | grip strength | Changes from baseline in physical examination at 12, 16 weeks | 
| visual test | traditional visual test in the letter C | Changes from baseline in physical examination at 12, 16 weeks | 
| hearing test (sec) | traditional hearing test with high frequency(4096Hz) and low frequency(512Hz) tuning fork | Changes from baseline in physical examination at 12, 16 weeks | 
| Activity of daily living (ADL) | This index measures the extent to which somebody can function independently and has bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care. Scores range from 0 to 100 with higher scores indicating greater independence. | Changes from baseline in ADL at 12, 16 weeks | 
| Instrumental Activities of Daily Living (IADL) | IADL's are activities related to independent living and include preparing meals, managing money, shopping for groceries or personal items, performing light or heavy housework, doing laundry, and using a telephone. The total score may range from 0 - 8. A lower score indicates a higher level of dependence. | Changes from baseline in physical examination at 12, 16 weeks | 
| Functional Independence Measure (FIM) | The Functional Independence Measure (FIM) scale assesses physical and cognitive disability. This scale focuses on the level of disability indicating the burden of caring for them. The scale includes 18 items. Each item is scored from 1 to 7 based on level of independence, where 1 represents total dependence and 7 indicates complete independence. Possible scores range from 18 to 126, with higher scores indicating more independence. | Changes from baseline in physical examination at 12, 16 weeks | 
| 36-Item Short Form Health Survey (SF-36) | The SF-36 consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Changes from baseline in physical examination at 12, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty syndrome, Intelligent POWER Rehabilitation Cluster Machine, Internet of Things, wearable