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

Frailty Syndrome Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02685839
• Other study ID #: 2015-06-003B
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 5, 2016
• Last updated: May 22, 2016
• Start date: May 2015
• Est. completion date: July 2018

Study information

• Verified date: May 2016
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frailty Syndrome
• Intelligent POWER Rehabilitation Cluster Machine

Intervention

Device:
• Intelligent POWER Rehabilitation Cluster Machine

Other:
• general physical therapy

Locations

Country	Name	City	State
Taiwan	Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. Review. — View Citation

Eriksson L, Lindström 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	balance test (sec)	single leg stance with eyes open	Changes from baseline in physical examination at 12, 16 weeks	Yes
Secondary	flexibility test_1st (cm)	truck flexion test in standing position	Changes from baseline in physical examination at 12, 16 weeks	Yes
Secondary	flexibility test_2nd (cm)	truck flexion test in sitting position	Changes from baseline in physical examination at 12, 16 weeks	No
Secondary	general mobility test (sec)	timed up and go test	Changes from baseline in physical examination at 12, 16 weeks	Yes
Secondary	hand-eye coordination test (sec)	grasp an falling rod	Changes from baseline in physical examination at 12, 16 weeks	No
Secondary	muscle endurance test (times/2 min)	step in place with hip raising to level	Changes from baseline in physical examination at 12, 16 weeks	Yes
Secondary	muscle strength test (kgw)	grip strength	Changes from baseline in physical examination at 12, 16 weeks	No
Secondary	visual test	traditional visual test in the letter C	Changes from baseline in physical examination at 12, 16 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No