Clinical trial NCT02685839: Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty Syndrome
Intelligent POWER Rehabilitation Cluster Machine
Keywords: frailty syndrome, Intelligent POWER Rehabilitation Cluster Machine, Internet of Things, wearable
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Tilburg Frailty Indicator (TFI)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
Secondary outcomes:
measure: balance test (sec)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: flexibility test_1st (cm)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: flexibility test_2nd (cm)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: general mobility test (sec)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: hand-eye coordination test (sec)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: muscle endurance test (times/2 min)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: muscle strength test (kgw)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: visual test
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: hearing test (sec)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: Activity of daily living (ADL)
timeFrame: Changes from baseline in ADL at 12, 16 weeks
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: Functional Independence Measure (FIM)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Changes from baseline in physical examination at 12, 16 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Si Huei Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pialoux T, Goyard J, Lesourd B. Screening tools for frailty in primary health care: a systematic review. Geriatr Gerontol Int. 2012 Apr;12(2):189-97. doi: 10.1111/j.1447-0594.2011.00797.x. Epub 2012 Jan 10.
citation: Fung J, Richards CL, Malouin F, McFadyen BJ, Lamontagne A. A treadmill and motion coupled virtual reality system for gait training post-stroke. Cyberpsychol Behav. 2006 Apr;9(2):157-62. doi: 10.1089/cpb.2006.9.157.
citation: Eriksson L, Lindstrom B, Ekenberg L. Patients' experiences of telerehabilitation at home after shoulder joint replacement. J Telemed Telecare. 2011;17(1):25-30. doi: 10.1258/jtt.2010.100317. Epub 2010 Nov 12.
citation: Cherney LR, van Vuuren S. Telerehabilitation, virtual therapists, and acquired neurologic speech and language disorders. Semin Speech Lang. 2012 Aug;33(3):243-57. doi: 10.1055/s-0032-1320044. Epub 2012 Jul 31.
citation: Sharma S, Ward EC, Burns C, Theodoros D, Russell T. Training the allied health assistant for the telerehabilitation assessment of dysphagia. J Telemed Telecare. 2012 Jul;18(5):287-91. doi: 10.1258/jtt.2012.111202. Epub 2012 Jul 11.