AzTrials
AzTrials

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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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
  • National Taiwan University Hospital

    Taipei, 108

    Der-Sheng Han, MD, 886-2-23717101 ext. 8401, dshan1121@yahoo.com.tw

    Recruiting

Other trials in Taiwan

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:

  1. Basic information: including gender, age, height, leg length, weight, medical history, medication, etc.
  2. 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.
  3. 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.
  4. Questionnaire: EuroQOL-5D will be used to evaluate their quality of life.
  5. 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.
  6. 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.
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 groups in NCT03858660
Study groupRoleWhat they receive
ElderlyHealthy elderly No intervention.
Receives: Other: No intervention

What is being measured

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

  1. Balance performance

    Forward reaching test

    Measured: 2 minutes

  2. Fitness

    flexibility test

    Measured: 2 minutes

  3. Lower extremity function

    2 minute step

    Measured: 2 minutes

  4. Muscle force

    weight lifting

    Measured: 2 minutes

  5. Endurence

    30sec sit-to-stand

    Measured: 2 minutes

  6. 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.

  1. First posted1 Mar 2019
  2. Study start23 Oct 2018
  3. Primary completion18 Sep 2019 (estimated)
  4. Study completion18 Sep 2019 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in