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

NCT ID: NCT02685839

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional rehabilitation

Each subject will do traditional rehabilitation work two times per week and one hour at a time

, lasting 24 weeks.

Group Type: ACTIVE_COMPARATOR

general physical therapy

Intervention Type: OTHER

Power rehabilitation

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.

Group Type: EXPERIMENTAL

Intelligent POWER Rehabilitation Cluster Machine

Intervention Type: DEVICE

Interventions

Intelligent POWER Rehabilitation Cluster Machine

Intervention Type: DEVICE

general physical therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Si Huei Lee

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 22233158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16640470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21075802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22851346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22790011 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

2015-06-003B

Identifier Type: -

Identifier Source: org_study_id