NCT03842215

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

February 13, 2019

Last Update Submit

June 30, 2021

Conditions

Keywords

smart physical examination systemhealth managementelderly

Outcome Measures

Primary Outcomes (8)

  • Single Leg Balance Test

    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

    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

    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

    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

    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

    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

    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)

    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.

Study Arms (1)

silver hair people

Exam subject's physical function by a smart physical exam

Device: smart physical exam

Interventions

Use smart physical exam to collect functional performance

silver hair people

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years old 2.people who can do movement by 3.people who can walk \>10m independently.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

RECRUITING

Related Publications (12)

  • Arias-Palencia NM, Solera-Martinez M, Gracia-Marco L, Silva P, Martinez-Vizcaino V, Canete-Garcia-Prieto J, Sanchez-Lopez M. Levels and Patterns of Objectively Assessed Physical Activity and Compliance with Different Public Health Guidelines in University Students. PLoS One. 2015 Nov 4;10(11):e0141977. doi: 10.1371/journal.pone.0141977. eCollection 2015.

    PMID: 26536605BACKGROUND
  • Choi JS, Kang DW, Seo JW, Kim DH, Yang ST, Tack GR. The development and evaluation of a program for leg-strengthening exercises and balance assessment using Kinect. J Phys Ther Sci. 2016 Jan;28(1):33-7. doi: 10.1589/jpts.28.33. Epub 2016 Jan 30.

    PMID: 26957724BACKGROUND
  • Franz-Ritscherle A, Lange DE. [Effectiveness of various audiovisual technics to improve oral hygiene behavior]. Dtsch Zahnarztl Z. 1983 Sep;38(9):811-5. No abstract available. German.

    PMID: 6196174BACKGROUND
  • Handrigan GA, Maltais N, Gagne M, Lamontagne P, Hamel D, Teasdale N, Hue O, Corbeil P, Brown JP, Jean S. Sex-specific association between obesity and self-reported falls and injuries among community-dwelling Canadians aged 65 years and older. Osteoporos Int. 2017 Feb;28(2):483-494. doi: 10.1007/s00198-016-3745-x. Epub 2016 Aug 25.

    PMID: 27562568BACKGROUND
  • Jorgensen MG. Assessment of postural balance in community-dwelling older adults - methodological aspects and effects of biofeedback-based Nintendo Wii training. Dan Med J. 2014 Jan;61(1):B4775.

    PMID: 24393594BACKGROUND
  • Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.

    PMID: 23114461BACKGROUND
  • King AC, Taylor CB, Haskell WL, Debusk RF. Strategies for increasing early adherence to and long-term maintenance of home-based exercise training in healthy middle-aged men and women. Am J Cardiol. 1988 Mar 1;61(8):628-32. doi: 10.1016/0002-9149(88)90778-3.

    PMID: 3344690BACKGROUND
  • Laufer Y, Dar G, Kodesh E. Does a Wii-based exercise program enhance balance control of independently functioning older adults? A systematic review. Clin Interv Aging. 2014 Oct 23;9:1803-13. doi: 10.2147/CIA.S69673. eCollection 2014.

    PMID: 25364238BACKGROUND
  • Palacios-Cena D, Ortiz-Gutierrez RM, Buesa-Estellez A, Galan-Del-Rio F, Cachon Perez JM, Martinez-Piedrola R, Velarde-Garcia JF, Cano-DE-LA-Cuerda R. Multiple sclerosis patients' experiences in relation to the impact of the kinect virtual home-exercise programme: a qualitative study. Eur J Phys Rehabil Med. 2016 Jun;52(3):347-55. Epub 2016 Feb 17.

    PMID: 26883340BACKGROUND
  • Santos-Eggimann B, Cuenoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10.

    PMID: 19276189BACKGROUND
  • Schutzer KA, Graves BS. Barriers and motivations to exercise in older adults. Prev Med. 2004 Nov;39(5):1056-61. doi: 10.1016/j.ypmed.2004.04.003.

    PMID: 15475041BACKGROUND
  • Walston J, McBurnie MA, Newman A, Tracy RP, Kop WJ, Hirsch CH, Gottdiener J, Fried LP; Cardiovascular Health Study. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med. 2002 Nov 11;162(20):2333-41. doi: 10.1001/archinte.162.20.2333.

    PMID: 12418947BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • TaSen Wei

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasen Wei, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 15, 2019

Study Start

January 18, 2019

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

only for search

Locations