NCT03858660

Brief 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. 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 Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model.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.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 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

October 23, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

February 26, 2019

Last Update Submit

July 30, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Balance performance

    Forward reaching test

    2 minutes

  • Fitness

    flexibility test

    2 minutes

  • Lower extremity function

    2 minute step

    2 minutes

  • Muscle force

    weight lifting

    2 minutes

  • Endurence

    30sec sit-to-stand

    2 minutes

  • Questionaire

    EuroQOL-5D

    5 minutes

Study Arms (1)

Elderly

Healthy elderly No intervention.

Other: No intervention

Interventions

No intervention

Elderly

Eligibility Criteria

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

Elderly

You may qualify if:

  • Normal upper extremity function
  • Walk for at least 10 meters without help

You may not qualify if:

  • Any conditions that could affect the balance function
  • Deficits in vision or hearing
  • Mental conditions that preclude the understanding of the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 108, Taiwan

RECRUITING

Study Officials

  • Der-Sheng Han, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Der-Sheng Han, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 1, 2019

Study Start

October 23, 2018

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations