NCT04354623

Brief Summary

Our group, consisting of academic clinicians and research engineers, seeks to create a database of stability measures (accelerometers, gyroscopes and altitude sensor data) in older adults monitored longitudinally. This Stability Measures (SM) database will allow us to use new machine learning methods to develop and then validate algorithms that predict future falls, allowing for better targeting of vulnerable patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
5 years until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 16, 2020

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Classification of accuracy of the algorithm on the validation dataset

    Consisting of True positive (TP), False positive (FP) rate, Precision, Recall (similar to sensitivity), F-measure (conveys the balance between precision and recall) and the Receiver Operation Curve area

    60 min

Study Arms (2)

High Risk Subjects (n=50)

All subjects will be recruited from falls and geriatrics clinics at Vancouver General Hospital. These clinics see about 2500 patients per year and are currently used for research recruitment. Each clinic patient has gait speed measured, which will allow to recruit both high and low risk fallers. This test will allow us to recruit 50 subjects at marked risk for falls, providing us with prospectively gathered dataset of greater than 100 events, five times higher than any other sensor study.

Other: A 6-minute walk test

Low Risk Subjects (n=50)

We will use newspaper advertisements to recruit and then screen low risk subjects. All subjects will have a gait speed \> 0.8 m/s and have had no falls in the last year.

Other: A 6-minute walk test

Interventions

Each subject will perform a 6-minute walk test during which gait assessment will be obtained from the APDM system (Portland, OR). In addition there will be four video cameras (on the front, back and sides) that will measure raw video data for our gait analysis. The camera does not record any facial data (in fact, 'deepfake' software in the system deletes all facial details) and the patient's movements are converted to a 'stick figure' prior to being saved in the system.

Also known as: Video recording
High Risk Subjects (n=50)Low Risk Subjects (n=50)

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We're planning to recruit 100 subjects from the Geriatric Medicine clinic at Vancouver General Hospital

You may qualify if:

  • All subjects must be aged 65 years and older • All subjects must have had at least one fall in the last year and have been referred to the falls clinic (High Risk Subjects) OR have had no falls on the last year and have responded to our newspaper advertisement (Low Risk Subjects)

You may not qualify if:

  • Subjects age less than 65 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Kenneth Madden, MD

    UBC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Vancouver General Hospital Division of Geriatric Medicine Department of Medicine University of British Columbia

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

April 15, 2025

Primary Completion

April 15, 2026

Study Completion

April 22, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations