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

May 22, 2016 updated by: Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional rehabilitation

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

, lasting 24 weeks.
Other: general physical therapy
Experimental: 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.
Device: Intelligent POWER Rehabilitation Cluster Machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tilburg Frailty Indicator (TFI)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
balance test (sec)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
single leg stance with eyes open
Changes from baseline in physical examination at 12, 16 weeks
flexibility test_1st (cm)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
truck flexion test in standing position
Changes from baseline in physical examination at 12, 16 weeks
flexibility test_2nd (cm)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
truck flexion test in sitting position
Changes from baseline in physical examination at 12, 16 weeks
general mobility test (sec)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
timed up and go test
Changes from baseline in physical examination at 12, 16 weeks
hand-eye coordination test (sec)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
grasp an falling rod
Changes from baseline in physical examination at 12, 16 weeks
muscle endurance test (times/2 min)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
step in place with hip raising to level
Changes from baseline in physical examination at 12, 16 weeks
muscle strength test (kgw)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
grip strength
Changes from baseline in physical examination at 12, 16 weeks
visual test
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
traditional visual test in the letter C
Changes from baseline in physical examination at 12, 16 weeks
hearing test (sec)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
traditional hearing test with high frequency(4096Hz) and low frequency(512Hz) tuning fork
Changes from baseline in physical examination at 12, 16 weeks
Activity of daily living (ADL)
Time Frame: Changes from baseline in ADL at 12, 16 weeks
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
Instrumental Activities of Daily Living (IADL)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
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
Functional Independence Measure (FIM)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
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
36-Item Short Form Health Survey (SF-36)
Time Frame: Changes from baseline in physical examination at 12, 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 22, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-06-003B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Clinical Study Report
  2. Clinical Study Report
  3. Clinical Study Report
  4. Clinical Study Report
  5. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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