- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592627
Facial and Body Motion Technology and Stroke
January 4, 2024 updated by: Jennifer Beauchamp, The University of Texas Health Science Center, Houston
Facial and Body Motion Technology to Detect Psychosocial Distress in Stroke Survivors and Informal Caregivers Living at Home
The purpose of this study is to customize privacy protected facial expression and body motion tracking for use in the home environment by stroke survivor-informal caregiver dyads by investigating within a simulated home environment, background variability,possible occlusions, privacy considerations, and the motor weaknesses, gait impairments, and facial expressions of stroke survivors and to determine the acceptability of the customized facial expression and body motion technology in stroke survivors and their informal caregivers.
Study Overview
Detailed Description
Stroke is a leading cause of disability.
Most stroke survivors are discharged home after hospitalization and receive care from informal caregivers (e.g., unpaid spouses) who are often unprepared for the role.
Stroke survivorship is an exemplar of a chronic condition that detracts from the affected individual and caregiver's capacity to live well within the home (e.g., psychosocial distress).
Early identification of psychosocial distress is likely to lead to timely interventions and, subsequently, decreases in associated morbidity, mortality, and disability.
Yet, only a minority of survivors are properly identified and treated for psychosocial distress, and caregivers are primarily forgotten.
In-home, objective measures to identify psychosocial distress are lacking.
Using facial expression and body motion technology by extracting facial characteristics and body joints (skeletal graph) known to be associated with psychosocial distress (e.g., frowning) provides new opportunities to support in-home telemonitoring.
To accommodate real-world, post-stroke home environments, the technology needs to be customized to an in-home environment.
Toward this end, the investigators must consider background variability, possible occlusions, privacy concerns, and stroke survivor motor weaknesses, gait impairments, and facial paralysis.
Objectives: The primary objectives are to customize facial expression and body motion technology and examine the acceptability of the technology through a study of 6 stroke survivor-informal caregiver dyads within a simulated home environment.
The project will serve as a necessary step to amass critical information to design future trials using facial expression and body motion technology.
The ultimate goal is to improve psychosocial well-being for those aging at home.
Study Type
Observational
Enrollment (Actual)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of 6 post-stroke survivor-informal caregiver dyads recruited from the UT Physicians Stroke Outpatient Clinic for a total of 12 study participants (6 stroke survivors and 6 informal caregivers of stroke survivors).
Description
Inclusion Criteria:
- can read, write, and speak English
- are willing and able to provide informed consent
- Informal caregivers must live in the home with the stroke survivor and be unpaid for their role
- Stroke survivors must have some degree of facial and limb weakness and a Modified Rankin Scale (mRS)13 score between 1 and 3.
Exclusion Criteria:
- stroke survivors currently reside outside of the home and are wheelchair bound.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Simulated home environment visit with the dyad participants
The cohort consists of six stroke survivor-informal caregiver (e.g., spouse or family member) dyads.
Individual dyads will participate in the simulated home environment visit while the investigative team collects the data.
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During the simulated home environment visit participants will 1) participate in a simulated University of Texas (UT) Physicians Stroke Outpatient Clinic telemedicine visit using an iPAD during which participants will be audio- and visually-recorded in order for the research team to collect raw facial expression data; 2) be instructed to complete a series of activities of daily living (e.g., sitting down and brushing hair) during which participants will be audio- and visually-recorded in order for the research team to collect raw body motion tracking data; and 3) complete a participant satisfaction survey via a REDCap link and participate in an audio-recorded, semi-structured interview (e.g., asking the participants thoughts on privacy considerations related to future use of the facial expression and body motion technology in a home environment) with members of the research team.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accuracy of the technology
Time Frame: During the procedure known as the simulated home environment visit
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The accuracy of a test is its ability to differentiate the patient and healthy cases correctly.
To estimate the accuracy of a test, we should calculate the proportion of true positive and true negative in all evaluated cases
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During the procedure known as the simulated home environment visit
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Sensitivity of the technology
Time Frame: During the procedure known as the simulated home environment visit
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The sensitivity of a test is its ability to determine the patient cases correctly.
To estimate it, we should calculate the proportion of true positive in patient cases.
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During the procedure known as the simulated home environment visit
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Specificity of the technology
Time Frame: During the procedure known as the simulated home environment visit
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The specificity of a test is its ability to determine the healthy cases correctly.
To estimate it, we should calculate the proportion of true negative in healthy cases
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During the procedure known as the simulated home environment visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability as measured by the patient satisfaction survey
Time Frame: Immediately after the procedure known as the stimulated home environment visit
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A 12-item survey title Participant Satisfaction Survey with 8 likert scale questions (e.g., strongly disagree to strongly agree answer options) and 4 open-ended questions.
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Immediately after the procedure known as the stimulated home environment visit
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Acceptability as measured by the open ended interview
Time Frame: Immediately after the procedure known as the stimulated home environment visit
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This will be an audio-recorded, semi-structured interview (e.g., asking the participants thoughts on privacy considerations related to future use of the facial expression and body motion technology in a home environment)
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Immediately after the procedure known as the stimulated home environment visit
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Acceptability as measured by field observations
Time Frame: During and immediately after the procedure known as the stimulated home environment visit
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Study team will capture field notes in REDCap database
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During and immediately after the procedure known as the stimulated home environment visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer E Beauchamp, PhD,RN,FAAN, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2020
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
October 7, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SN-20-0686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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