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Frailty SyndromeNCT02685839

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

A study testing Intelligent POWER Rehabilitation Cluster Machine and general physical therapy in people with Frailty Syndrome and Intelligent POWER Rehabilitation Cluster Machine, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 85 years
What is being tested?
Intelligent POWER Rehabilitation Cluster Machine and general physical therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
May 2015to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center

    Taipei, 11217

Other trials in Taiwan

About this study

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.

Read more

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.

Being tested
Intelligent POWER Rehabilitation Cluster Machine, general physical therapy
Keywords
frailty syndrome, Intelligent POWER Rehabilitation Cluster Machine, Internet of Things, wearable
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intelligent POWER Rehabilitation Cluster MachineDevice

  • general physical therapyOther

Study groups in NCT02685839
Study groupRoleWhat they receive
Traditional rehabilitationActive comparatorEach subject will do traditional rehabilitation work two times per week and one hour at a time , lasting 24 weeks.
Receives: Other: general physical therapy
Power rehabilitationExperimentalEach 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.
Receives: Device: Intelligent POWER Rehabilitation Cluster Machine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Changes from baseline in physical examination at 12, 16 weeks

Secondary outcomes (13)

  1. balance test (sec)

    single leg stance with eyes open

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  2. flexibility test_1st (cm)

    truck flexion test in standing position

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  3. flexibility test_2nd (cm)

    truck flexion test in sitting position

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  4. general mobility test (sec)

    timed up and go test

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  5. hand-eye coordination test (sec)

    grasp an falling rod

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  6. muscle endurance test (times/2 min)

    step in place with hip raising to level

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  7. muscle strength test (kgw)

    grip strength

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  8. visual test

    traditional visual test in the letter C

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  9. hearing test (sec)

    traditional hearing test with high frequency(4096Hz) and low frequency(512Hz) tuning fork

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  10. 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.

    Measured: Changes from baseline in ADL at 12, 16 weeks

  11. 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.

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  12. 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.

    Measured: Changes from baseline in physical examination at 12, 16 weeks

  13. 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.

    Measured: Changes from baseline in physical examination at 12, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2016 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02685839
Sponsor's protocol ID
2015-06-003B
Status last verified
May 2016
First submitted
5 Jan 2016
Last updated
24 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22233158

  • 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.

    PubMed 16640470

  • 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.

    PubMed 21075802

  • 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.

    PubMed 22851346

  • 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.

    PubMed 22790011

Questions about this trial

What is this clinical trial studying?

A study testing Intelligent POWER Rehabilitation Cluster Machine and general physical therapy in people with Frailty Syndrome and Intelligent POWER Rehabilitation Cluster Machine, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tilburg Frailty Indicator (TFI) (time frame: Changes from baseline in physical examination at 12, 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02685839, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.

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