A Smart Physical Examination System for the Health Management in Elderly

June 30, 2021 updated by: Changhua Christian Hospital

Development and Clinical Applications of a Smart Physical Examination System for the Health Management in Elderly

The object of this study is to develop a smart physical examination system targeted on the unmet need of the elderly.Furthermore,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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model.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. Following the principle of commercialization, this project aims at working out the product prototype, finalize the assessment tools/algorithm, and put it into the clinical trials. The project research team comprising the physicians, therapists, hardware and software systems engineering experts, with the early manufacturing involvement from the industry partner. The team members will work closely to solve the clinical, engineering, and market demand issues during the development process. The project will build a platform to deepen the bilateral understanding and research cooperation to solve the aging society problem. 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Tasen Wei, Doctor
  • Phone Number: 7416 886-4-7238598
  • Email: 10945@cch.org.tw

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community-dwelling people who are recruited from the local community, hospital, club.

Description

Inclusion Criteria:

1.55-85 years old 2.people who can do movement by 3.people who can walk >10m independently.

Exclusion Criteria:

  1. people who implant cardiac rhythm, have cardiac arrhythmia,tumor,infection,or any other internal disease.
  2. people who have visual disturbance (Corrected vision<4.0 or any ophthalmic diseases caused bad eyesight),hearing loss,movement disorder.
  3. people who can't stand stably.
  4. people who can't fill out a questionnaire independently.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
silver hair people
Exam subject's physical function by a smart physical exam
Device: smart physical exam
Use smart physical exam to collect functional performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Leg Balance Test
Time Frame: Test once while subject is recruited.

Remove the shoes and stand on the floor. Stand on one leg for 60 seconds and record the duration (seconds) that subject keeps one leg stand.

The test is stopped

  1. if the legs touch each other,
  2. if the weight-bearing foot moves on the floor,
  3. if the non-weight bearing foot touches the floor
  4. if the hands are removed from the waist.
Test once while subject is recruited.
Functional Reach Test
Time Frame: Test once while subject is recruited.

Position the patient close to the wall. The patient is instructed to stand with feet shoulder distance apart then make a fist and raise the arm up so that it's parallel to the floor.

At this time, the practitioner takes an initial reading on the yardstick, usually spotting the knuckle of the third metacarpal.

The patient is instructed to reach forward along the yardstick without moving the feet, the hand should remain in a fist.

The practitioner takes a reading on the yardstick of the farthest reach (cm) attained by the patient without taking a step.
Test once while subject is recruited.
Chair Sit and Reach Test
Time Frame: Test once while subject is recruited.

The subject sits on the edge of a chair. One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Place one hand on top of the other with tips of the middle fingers even. Instruct the subject to Inhale, and then as they exhale, reach forward toward the toes by bending at the hip. Keep the back straight and head up.

Keep the knee straight, and hold the reach for 2 seconds. The distance is measured between the tip of the fingertips and the toes. If the fingertips touch the toes then the score is zero. If they do not touch, measure the distance between the fingers and the toes (a negative score), if they overlap, measured by how much (a positive score). Perform two trials.

The score is recorded to the nearest 1/2 inch or 1 cm as the distance reached, either a negative or positive score. Record which leg was used for measurement.
Test once while subject is recruited.
2 minute step
Time Frame: Test once while subject is recruited.
The subject stands up straight next to the wall while a mark is placed on the wall at the level corresponding to midway between the patella (knee cap) and iliac crest (top of the hip bone). The subject then marches in place for two minutes, lifting the knees to the height of the mark on the wall. Resting is allowed, and holding onto the wall or a stable chair is allowed. Stop after two minutes of stepping, and measure the heart rate (beats/min).
Test once while subject is recruited.
Arm Curl Test
Time Frame: Test once while subject is recruited.

The aim of this test is to do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side. The subject sits on the chair, holding the weight in the hand using a suitcase grip with the arm in a vertically down position beside the chair. Brace the upper arm against the body so that only the lower arm is moving. Curl the arm up through a full range of motion, gradually turning the palm up (flexion with supination). As the arm is lowered through the full range of motion, gradually return to the starting position. The arm must be fully bent and then fully straightened at the elbow. Repeat this action as many times as possible within 30 seconds.

The repetitions of arm curl are recorded.
Test once while subject is recruited.
30-sec sit -to-stand
Time Frame: Test once while subject is recruited.

Use 30-Second sit to stand to test leg strength and endurance.

  1. Sit in the middle of the chair.
  2. Place your hands on the opposite shoulder crossed, at the wrists.
  3. Keep your feet flat on the floor.
  4. Keep your back straight, and keep your arms against your chest.
  5. On "Go," rise to a full standing position, then sit back down again.
  6. Repeat this for 30 seconds.
  7. Record the repetitions is performed.
Test once while subject is recruited.
Euro QOL-5D
Time Frame: Test once while subject is recruited.

The Euro QOL-5D (EQ-5D) comprises five questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem).

A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores.

The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analog scale (VAS) to indicate the general health status with 100 indicating the best health status.
Test once while subject is recruited.
International Physical Activity Questionnaire (IPAQ)
Time Frame: Test once while subject is recruited.

IPAQ comprises a set of 4 questionnaires and will ask about the time the subject spent being physically active in the last 7 days.

Three levels (categories) of physical activity are proposed:

Category 1: Low Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive.

Category 2: Moderate

Any one of the following 3 criteria:

  • 3 or more days of vigorous activity of at least 20 minutes per day OR
  • 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR
  • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.

Category 3: High

Any one of the following 2 criteria:

  • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR
  • 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Test once while subject is recruited.

Collaborators and Investigators

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

Sponsor

Changhua Christian Hospital

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 (Actual)

January 18, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCH-181211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

only for search

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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