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

NCT02685839 | Unknown

• 1 other identifier: 2015-06-003B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome; Intelligent POWER Rehabilitation Cluster Machine

Keywords

frailty syndrome, Intelligent POWER Rehabilitation Cluster Machine, Internet of Things, wearable

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

• 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

• hand-eye coordination test (sec)

  Changes from baseline in physical examination at 12, 16 weeks

Study Arms (2)

Traditional rehabilitation

ACTIVE COMPARATOR

Each subject will do traditional rehabilitation work two times per week and one hour at a time , lasting 24 weeks.

Other: general physical therapy

Power rehabilitation

EXPERIMENTAL

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

Interventions

Intelligent POWER Rehabilitation Cluster Machine DEVICE

Power rehabilitation

general physical therapy OTHER

Traditional rehabilitation

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60 to 85
• Cardiovascular Health Study (CHS) frailty criteria
• willing to sign agreement

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center

Taipei, 11217, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 22233158 BACKGROUND

• 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.

  PMID: 16640470 BACKGROUND

• 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.

  PMID: 21075802 BACKGROUND

• 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.

  PMID: 22851346 BACKGROUND

• 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.

  PMID: 22790011 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Si Huei Lee

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: February 19, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2018
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

TW (1)