NCT04324333

Brief Summary

The long-term goals of the project are: 1) Preventing falls before they occur, by significantly improving our ability to monitor fall risk and develop early and sensitive markers for this risk, based on tripping and near falls and other physiological signs, 2) automatically diagnosing falls within seconds from the time of the incident, without the need for an emergency / distress button or making a phone call.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

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

September 9, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

5.3 years

First QC Date

March 23, 2020

Last Update Submit

March 29, 2020

Conditions

Fall Patients

Keywords

FallsFalls Prevention in Older AgeAutomated detection of misstepsFall Risk

Outcome Measures

Primary Outcomes (3)

  • Physical Activity

    The International Physical Activity Questionnaires (IPAQ-short). It will quantify the health-related physical activity.

    One week post monitoring period

  • Community ambulation

    A body-worn small lightweight device (6-Axis Logging Accelerometer) that will be worn by the subject for 7 days to monitor ADL.

    One week post monitoring period

  • The frequency of falling

    The subjects are asked to fill in monthly Fall log (Frequency and circumstances of falls if occurred)

    One week post monitoring period

Secondary Outcomes (2)

  • Changes in endurance

    One week post monitoring period

  • Improve in motor function

    One week post monitoring period

Study Arms (1)

Using Digital wearable system for fall detection

EXPERIMENTAL

Digital wearable system (Owlytics Healthcare's app) enables a 24/7 health-tracking service, collecting personal health data from wearable wristbands and insoles. The data is analyzed by machine-learning algorithms that can detect abnormal physiological patterns. This allows the prediction and prevention of potentially harmful health events (such as falls).

Behavioral: Digital wearable system

Interventions

Digital wearable systemBEHAVIORAL

Owlytics Healthcare's system is dedicated to improving the lives of all seniors by using the predictive power of data analytics.

Also known as: Digital wearable system (Owlytics Healthcare's app)
Using Digital wearable system for fall detection

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old;
  • Ambulatory without help from another person (with or without use of walking aid);
  • Able to follow simple directions (Mini Mental State Examination score \>21);
  • Community-living or assisted living housing for elderly.

You may not qualify if:

  • Subjects who will not be able to wear the devices for more than a 1 week period during the 4 months following their baseline evaluation (planning on traveling out of town, etc.);
  • Patients who are not able to deal with the device and do not family member or therapist who is willing to help with the system;
  • A state of health that does not allow participation in research and testing, or who has not agreed to participate in the study, or is unable to understand and follow simple instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (2)

  • Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6. doi: 10.1053/apmr.2001.24893.

    PMID: 11494184BACKGROUND

  • Mackenzie L, Byles J, D'Este C. Validation of self-reported fall events in intervention studies. Clin Rehabil. 2006 Apr;20(4):331-9. doi: 10.1191/0269215506cr947oa.

    PMID: 16719031BACKGROUND

Related Links

Central Study Contacts

Marina Brozol, Ms

CONTACT

+972-3-6947513marinab@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 27, 2020

Study Start

September 9, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

IL(1)