Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment
Primary Purpose
Frailty Syndrome, Intelligent POWER Rehabilitation Cluster Machine
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intelligent POWER Rehabilitation Cluster Machine
general physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Frailty Syndrome focused on measuring frailty syndrome, Intelligent POWER Rehabilitation Cluster Machine, Internet of Things, wearable
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
Sites / Locations
- Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional rehabilitation
Power rehabilitation
Arm Description
Each subject will do traditional rehabilitation work two times per week and one hour at a time , lasting 24 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
balance test (sec)
single leg stance with eyes open
flexibility test_1st (cm)
truck flexion test in standing position
flexibility test_2nd (cm)
truck flexion test in sitting position
general mobility test (sec)
timed up and go test
hand-eye coordination test (sec)
grasp an falling rod
muscle endurance test (times/2 min)
step in place with hip raising to level
muscle strength test (kgw)
grip strength
visual test
traditional visual test in the letter C
hearing test (sec)
traditional hearing test with high frequency(4096Hz) and low frequency(512Hz) tuning fork
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.
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.
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.
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.
Full Information
NCT ID
NCT02685839
First Posted
January 5, 2016
Last Updated
May 22, 2016
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02685839
Brief Title
Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome, Intelligent POWER Rehabilitation Cluster Machine
Keywords
frailty syndrome, Intelligent POWER Rehabilitation Cluster Machine, Internet of Things, wearable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional rehabilitation
Arm Type
Active Comparator
Arm Description
Each subject will do traditional rehabilitation work two times per week and one hour at a time
, lasting 24 weeks.
Arm Title
Power rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intelligent POWER Rehabilitation Cluster Machine
Intervention Type
Other
Intervention Name(s)
general physical therapy
Primary Outcome Measure Information:
Title
Tilburg Frailty Indicator (TFI)
Description
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.
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Secondary Outcome Measure Information:
Title
balance test (sec)
Description
single leg stance with eyes open
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
flexibility test_1st (cm)
Description
truck flexion test in standing position
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
flexibility test_2nd (cm)
Description
truck flexion test in sitting position
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
general mobility test (sec)
Description
timed up and go test
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
hand-eye coordination test (sec)
Description
grasp an falling rod
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
muscle endurance test (times/2 min)
Description
step in place with hip raising to level
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
muscle strength test (kgw)
Description
grip strength
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
visual test
Description
traditional visual test in the letter C
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
hearing test (sec)
Description
traditional hearing test with high frequency(4096Hz) and low frequency(512Hz) tuning fork
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
Activity of daily living (ADL)
Description
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.
Time Frame
Changes from baseline in ADL at 12, 16 weeks
Title
Instrumental Activities of Daily Living (IADL)
Description
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.
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
Title
36-Item Short Form Health Survey (SF-36)
Description
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.
Time Frame
Changes from baseline in physical examination at 12, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Si Huei Lee
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Power Rehabilitation Room, Taipei Veterans General Hospital Integrative Rehabilitation Center
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22233158
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.
Results Reference
background
PubMed Identifier
16640470
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. doi: 10.1089/cpb.2006.9.157.
Results Reference
background
PubMed Identifier
21075802
Citation
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.
Results Reference
background
PubMed Identifier
22851346
Citation
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.
Results Reference
background
PubMed Identifier
22790011
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://drive.google.com/file/d/0B2qKUXYO2VcCQkJYbVpvZERWZ2tOdkc2LW4tTHYtNkYxd0NF/view?usp=sharing
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://drive.google.com/file/d/0B2qKUXYO2VcCTTMxQlZMeWZId3Vvd3F5RnFJa28wZm1ka3Z3/view?usp=sharing
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://drive.google.com/file/d/0B2qKUXYO2VcCODdSaE1TM05TOE9Pc1RnR0Z2NGw1d3FjdzBJ/view?usp=sharing
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://drive.google.com/file/d/0B2qKUXYO2VcCdnlCVzRJUFlqcURZYzJ3VkJYNjlnaXcwU3F3/view?usp=sharing
Learn more about this trial
Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment
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