Conditions Influencing Health StatusNCT03858660
Clinical Applications of a Smart Physical Examination System for the Health Management in Elderly
An observational study of Conditions Influencing Health Status, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aging usually results in a decline in motor function. However, the elderly tend to refuse the regular health examination because of travel issues or lack of self-health awareness. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Oct 2018to 18 Sep 2019
- Phase
- Observational
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly
Who may be able to join
- Normal upper extremity function
- Walk for at least 10 meters without help
Who cannot join
- Any conditions that could affect the balance function
- Deficits in vision or hearing
- Mental conditions that preclude the understanding of the protocol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 108
Der-Sheng Han, MD, 886-2-23717101 ext. 8401, dshan1121@yahoo.com.tw
About this study
Official title: Physical Examination for Health Management in Elderly
Aging usually results in a decline in motor function. However, the elderly tend to refuse the regular health examination because of travel issues or lack of self-health awareness. Examination unit also has difficulty to intensively track and instant feedback on the health status of the elderly due to insufficient manpower. If the elderly go to the hospital only when the health problem is getting worse, his/her health is often irreversible and the cost of medical care would be increased. It is therefore an essential issue for the early detection of functional changes in the elderly to prevent the deterioration of the health and function. Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model. The wearing and operation issues of the wearable devices used for health management are still a gap affecting the acceptance of the elderly. Accordingly, the objective of this project is to develop a handy and easy-to-use smart physical examination system for the elderly. With the use of motion-sensing and big data analysis technology, the non-contact professional and intelligent assessment could simplify the general health checkup procedures to promote the health management and to reduce the manpower cost of health care. The ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in the elderly.
Read the detailed description
[Introduction] Aging usually results in a decline of motor function. However, elderly tends to refuse the regular health examination because of travel issues or lack of self-health awareness. Examination unit also has difficulty to intensively track and instantly feedback the health status of elderly due to insufficient manpower. If elderly goes to the hospital only when the health problem is getting worse, his/her health is often irreversible and the cost of medical care would be increased. It is therefore an essential issue for the early detection of functional changes in elderly to prevent the deterioration of the health and function. Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model. The wearing and operation issues of the wearable devices used for health management are still a gap affecting the acceptance of elderly. Accordingly, the objective of this project is to develop a handy and easy-to-use smart physical examination system targeted on the unmet need of the elderly. With the use of motion-sensing and big data analysis technology, the non-contact professional and intelligent assessment could simplify the general health checkup procedures to promote the health management and to reduce the manpower cost of health care. The ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly.
In this study, a new type of home-based health assessment platform will be proposed. The main purpose is to help the elderly who may not be able to go to the hospital or health unit for regular health check because of inconvenience to physical activity. The current health assessment mode is also insufficient because Human and resource could not provide a more intensive frequency of health testing. The physical condition of the elderly may rapidly decline into a systemic disability due to some minor diseases. Therefore, the current limited resource inspection mode cannot effectively monitor and recover the elderly's physical condition. The home-based health assessment platform developed in this study can evaluate the user's health status in hospitals, communities, or home environments. The non-contact evaluation method allows users to start testing without wearing any device, which can effectively improve The user's acceptance of health testing and rapid grading of the user's health will also help to further design a personalized rehabilitation training program in the future.
[Method]
Subject:
Inclusion criteria: 1) aged between 55-85 years old. 2) normal upper extremity function. 3) walk for at least 10 meters without help.
Exclusion criteria: 1) any disease that could affect balance. 2) deficits in vision or hearing. 3) mental issues preclude from the understanding of the protocol.
Protocol:
- Basic information: including gender, age, height, leg length, weight, medical history, medication, etc.
- Clinical functional assessment: The results of following tests evaluated by the Kinect-based health management platform will be compared with those of the physical examination conducted by experts such as clinicians and therapists.
- Flexibility test: The subjects sit in a chair with no backrest and backrest. One foot bent stably on the ground and one foot extended forward (knee joint must be straight). The heel hits the ground and the foot was in neutral position. They are then asked to overlap the hands and straighten the upper body forward slowly, trying to touch the toes in the middle pointing and holding for 2 seconds. The distance between the middle finger and the toes is then measured. The test are repeated twice and the better measured value will be recorded. ii. Endurance test: evaluated by the 2-minute stepping test. iii. Muscle strength: Upper limb strength is assessed using a 30-second arm curl test. And the lower limb strength is assessed by the 30-second sit-to-stand test. iv. Balance test: The subjects are asked to stand on the force plate looking straight ahead with feet in shoulder width. There are two kinds of standing test situations: i) single leg standing for a maximum of 60 seconds; ii) forward reaching as the arms straight and parallel to the ground and remain in the maximum extended position for two seconds.
- Questionnaire: EuroQOL-5D will be used to evaluate their quality of life.
- Data analysis: The concurrent validity of the Kinect-based health management platform will be analyzed by the Pearson Correlation. And the balance parameters will be evaluated by the movement of center of the pressure.
- Adverse reactions and management: All the tests are non-invasive, so we won't expect any major side effects. If the patient feels uncomfortable or feels dizzy during the fitness test, he can stop the test, lie down and rest at any time, and the on-site medical staff will monitor their breathing, heartbeat, and blood pressure to assess whether additional treatment is required.
- Conditions
- Conditions Influencing Health Status
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Healthy elderly No intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance performance
Forward reaching test
Measured: 2 minutes
Fitness
flexibility test
Measured: 2 minutes
Lower extremity function
2 minute step
Measured: 2 minutes
Muscle force
weight lifting
Measured: 2 minutes
Endurence
30sec sit-to-stand
Measured: 2 minutes
Questionaire
EuroQOL-5D
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start23 Oct 2018
- Primary completion18 Sep 2019 (estimated)
- Study completion18 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions Influencing Health StatusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Der-Sheng Han, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858660
- Sponsor's protocol ID
- 201807156DINC
- Status last verified
- Jul 2019
- First submitted
- 26 Feb 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Examination for Health Management in Elderly
- ClinicalTrials.gov ID
- NCT03858660
- Acronym / sponsor ID
- 201807156DINC
- Conditions
- Conditions Influencing Health Status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 18 Sep 2019 (estimated)
- Study completion
- 18 Sep 2019 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aging usually results in a decline in motor function. However, the elderly tend to refuse the regular health examination because of travel issues or lack of self-health awareness. Examination unit also has difficulty to intensively track and instant feedback on the health status of the elderly due to insufficient manpower. If the elderly go to the hospital only when the health problem is getting worse, his/her health is often irreversible and the cost of medical care would be increased. It is therefore an essential issue for the early detection of functional changes in the elderly to prevent the deterioration of the health and function. Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model. The wearing and operation issues of the wearable devices used for health management are still a gap affecting the acceptance of the elderly. Accordingly, the objective of this project is to develop a handy and easy-to-use smart physical examination system for the elderly. With the use of motion-sensing and big data analysis technology, the non-contact professional and intelligent assessment could simplify the general health checkup procedures to promote the health management and to reduce the manpower cost of health care. The ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in the elderly.
Detailed description
[Introduction] Aging usually results in a decline of motor function. However, elderly tends to refuse the regular health examination because of travel issues or lack of self-health awareness. Examination unit also has difficulty to intensively track and instantly feedback the health status of elderly due to insufficient manpower. If elderly goes to the hospital only when the health problem is getting worse, his/her health is often irreversible and the cost of medical care would be increased. It is therefore an essential issue for the early detection of functional changes in elderly to prevent the deterioration of the health and function. Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model. The wearing and operation issues of the wearable devices used for health management are still a gap affecting the acceptance of elderly. Accordingly, the objective of this project is to develop a handy and easy-to-use smart physical examination system targeted on the unmet need of the elderly. With the use of motion-sensing and big data analysis technology, the non-contact professional and intelligent assessment could simplify the general health checkup procedures to promote the health management and to reduce the manpower cost of health care. The ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly.
In this study, a new type of home-based health assessment platform will be proposed. The main purpose is to help the elderly who may not be able to go to the hospital or health unit for regular health check because of inconvenience to physical activity. The current health assessment mode is also insufficient because Human and resource could not provide a more intensive frequency of health testing. The physical condition of the elderly may rapidly decline into a systemic disability due to some minor diseases. Therefore, the current limited resource inspection mode cannot effectively monitor and recover the elderly's physical condition. The home-based health assessment platform developed in this study can evaluate the user's health status in hospitals, communities, or home environments. The non-contact evaluation method allows users to start testing without wearing any device, which can effectively improve The user's acceptance of health testing and rapid grading of the user's health will also help to further design a personalized rehabilitation training program in the future.
[Method]
Subject:
Inclusion criteria: 1) aged between 55-85 years old. 2) normal upper extremity function. 3) walk for at least 10 meters without help.
Exclusion criteria: 1) any disease that could affect balance. 2) deficits in vision or hearing. 3) mental issues preclude from the understanding of the protocol.
Protocol:
- Basic information: including gender, age, height, leg length, weight, medical history, medication, etc.
- Clinical functional assessment: The results of following tests evaluated by the Kinect-based health management platform will be compared with those of the physical examination conducted by experts such as clinicians and therapists.
- Flexibility test: The subjects sit in a chair with no backrest and backrest. One foot bent stably on the ground and one foot extended forward (knee joint must be straight). The heel hits the ground and the foot was in neutral position. They are then asked to overlap the hands and straighten the upper body forward slowly, trying to touch the toes in the middle pointing and holding for 2 seconds. The distance between the middle finger and the toes is then measured. The test are repeated twice and the better measured value will be recorded. ii. Endurance test: evaluated by the 2-minute stepping test. iii. Muscle strength: Upper limb strength is assessed using a 30-second arm curl test. And the lower limb strength is assessed by the 30-second sit-to-stand test. iv. Balance test: The subjects are asked to stand on the force plate looking straight ahead with feet in shoulder width. There are two kinds of standing test situations: i) single leg standing for a maximum of 60 seconds; ii) forward reaching as the arms straight and parallel to the ground and remain in the maximum extended position for two seconds.
- Questionnaire: EuroQOL-5D will be used to evaluate their quality of life.
- Data analysis: The concurrent validity of the Kinect-based health management platform will be analyzed by the Pearson Correlation. And the balance parameters will be evaluated by the movement of center of the pressure.
- Adverse reactions and management: All the tests are non-invasive, so we won't expect any major side effects. If the patient feels uncomfortable or feels dizzy during the fitness test, he can stop the test, lie down and rest at any time, and the on-site medical staff will monitor their breathing, heartbeat, and blood pressure to assess whether additional treatment is required.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Other: No interventionHealthy elderly No intervention. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly
Key inclusion criteria (2 listed)
- Normal upper extremity function
- Walk for at least 10 meters without help
Key exclusion criteria (3 listed)
- Any conditions that could affect the balance function
- Deficits in vision or hearing
- Mental conditions that preclude the understanding of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Elderly |
Primary outcome
Balance performance
Time frame: 2 minutes
Forward reaching test
Fitness
Time frame: 2 minutes
flexibility test
Lower extremity function
Time frame: 2 minutes
2 minute step
Muscle force
Time frame: 2 minutes
weight lifting
Endurence
Time frame: 2 minutes
30sec sit-to-stand
Questionaire
Time frame: 5 minutes
EuroQOL-5D
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Der-Sheng Han, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conditions Influencing Health Status, run by National Taiwan University Hospital 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 2 inclusion and 3 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 1 Aug 2019. 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?
Contact Der-Sheng Han, MD (886-2-23717101 ext. 8401, dshan1121@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance performance (time frame: 2 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2019.