- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034302
Posture Analysis Through Machine Learning (PathML)
Study Overview
Status
Conditions
Detailed Description
This is a cross-sectional, single observation study. Individuals will be drawn from local surrounding clinics and the general community. All recruitment will include both men and women. Selection criteria include individuals between the ages of 18-85 years, no major chronic illness that impair mobility and able to complete activities of daily living without assistance. Participants will complete one three hour session where there will be one video camera set up within the home (i.e., static cameras). For approximately 30 minutes of the session they will complete a semi-scripted routine that will include sit to stand transitions, a timed up and go test, and scripted activities of daily living.
Researchers will use a video camera to record participant behavior within their daily life. For two of the three hours, researchers will be video recordings the participants normal (unscripted) activities. • For one hour of the session we will use two cameras, one that will be held by a researcher and one that will be set up on a tripod. During this hour we will ask participants to follow a semi-structured protocol:
- 10 minutes recording the empty space
- 10 minutes that include a timed up a go test (sit up from a chair and walk 10 feet), repeat the test 3 times.
- 6 minute walk test (walk continuously for 6 minutes)
- Four stage balance test
- The remainder of the time, participants will complete standard activities of daily living like household chores, eating or drinking.
Data will be annotated using an established behavioral observation software by training research assistants (ground-truth). The image data from videos will be used to train machine learning models to classify physical activities (e.g. ,'walking', 'sitting' or 'standing up"), information about behavior (e.g., location and purpose of the activity), and performance (e.g., walking speed and sit to stand transition times).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
San Luis Obispo, California, United States, 93407
- CalPoly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-85 years
- No major chronic illness that impair mobility
- Able to complete activities of daily living without assistance.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Recordings
Selection criteria include individuals between the ages of 18-85 years, no major chronic illness that impair mobility and able to complete activities of daily living without assistance.
We will recruit approximately equal number of men and women and 30% of the sample will be racial or ethnic minorities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Status
Time Frame: Upon enrollment (one timepoint)
|
Sitting versus standing versus moving
|
Upon enrollment (one timepoint)
|
|
Activity type
Time Frame: Upon enrollment (one timepoint)
|
Indoor vs outdoor vs driving
|
Upon enrollment (one timepoint)
|
|
Sit to stand transition time
Time Frame: Upon enrollment (one timepoint)
|
Time it takes to go from sitting to standing
|
Upon enrollment (one timepoint)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity intensity
Time Frame: Upon enrollment (one timepoint)
|
Sedentary, light, moderate and vigorous intensity
|
Upon enrollment (one timepoint)
|
|
Activity type
Time Frame: Upon enrollment (one timepoint)
|
lying, sitting, driving, standing, housework or office work, walking, running, sports, other
|
Upon enrollment (one timepoint)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Keadle, Cal Poly
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PathML2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.