Health BehaviorPathMLNCT05034302
Posture Analysis Through Machine Learning
An observational study of Health Behavior, run by SentiMetrix, Inc at 1 site in United States.
Trial summary
This study will include video-recorded data from 20 adults (age 18-85yrs) residing in San Luis Obispo, CA. Participants will also have their height and weight measured, complete demographic questionnaires, and one 3hour session with video recordings in a combination of naturalistic condition and semi-structured… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Health Behavior
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Generally health adult population recruited from local community
Who may be able to join
- Age 18-85 years
- No major chronic illness that impair mobility
- Able to complete activities of daily living without assistance.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study will include video-recorded data from 20 adults (age 18-85yrs) residing in San Luis Obispo, CA. Participants will also have their height and weight measured, complete demographic questionnaires, and one 3hour session with video recordings in a combination of naturalistic condition and semi-structured environments. The video data will be used to train machine learning models to automatically classify physical behavior as compared to ground-truth measures of manual annotation.
Read the 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).
- Conditions
- Health Behavior
- Keywords
- adult, behavioral observation, methodology, computer vision
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Postural Status
Sitting versus standing versus moving
Measured: Upon enrollment (one timepoint)
Activity type
Indoor vs outdoor vs driving
Measured: Upon enrollment (one timepoint)
Sit to stand transition time
Time it takes to go from sitting to standing
Measured: Upon enrollment (one timepoint)
Secondary outcomes (2)
Activity intensity
Sedentary, light, moderate and vigorous intensity
Measured: Upon enrollment (one timepoint)
Activity type
lying, sitting, driving, standing, housework or office work, walking, running, sports, other
Measured: Upon enrollment (one timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Nov 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SentiMetrix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Polytechnic State University-San Luis Obispo
- Responsible party
- Principal investigator, Vadim Kagan, SentiMetrix, Inc
- Investigators
- Sarah Keadle, Principal investigator, Cal Poly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034302
- Sponsor's protocol ID
- PathML2021
- Acronym
- PathML
- Status last verified
- May 2022
- First submitted
- 27 Aug 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Analysis Through Machine Learning
- ClinicalTrials.gov ID
- NCT05034302
- Acronym / sponsor ID
- PathML / PathML2021
- Conditions
- Health Behavior
- Keywords
- adult, behavioral observation, methodology, computer vision
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SentiMetrix, IncIndustry (pharma, biotech, devices)
- Collaborators
- California Polytechnic State University-San Luis Obispo
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will include video-recorded data from 20 adults (age 18-85yrs) residing in San Luis Obispo, CA. Participants will also have their height and weight measured, complete demographic questionnaires, and one 3hour session with video recordings in a combination of naturalistic condition and semi-structured environments. The video data will be used to train machine learning models to automatically classify physical behavior as compared to ground-truth measures of manual annotation.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Generally health adult population recruited from local community
Key inclusion criteria (3 listed)
- Age 18-85 years
- No major chronic illness that impair mobility
- Able to complete activities of daily living without assistance.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postural Status
Time frame: Upon enrollment (one timepoint)
Sitting versus standing versus moving
Activity type
Time frame: Upon enrollment (one timepoint)
Indoor vs outdoor vs driving
Sit to stand transition time
Time frame: Upon enrollment (one timepoint)
Time it takes to go from sitting to standing
2 secondary outcomes
Activity intensity
Time frame: Upon enrollment (one timepoint)
Activity type
Time frame: Upon enrollment (one timepoint)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Keadle principal investigator
Cal Poly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by SentiMetrix, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Status (time frame: Upon enrollment (one timepoint)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.