StrokeNCT04592627
Facial and Body Motion Technology and Stroke
An observational study of Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Simulated home environment visit
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 1 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- stroke survivors currently reside outside of the home and are wheelchair bound.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Simulated home environment visit
- Keywords
- Stroke, caregiver, technology, psychosocial, aging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated home environment visitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Simulated home environment visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the technology
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
Measured: During the procedure known as the simulated home environment visit
Sensitivity of the technology
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.
Measured: During the procedure known as the simulated home environment visit
Specificity of the technology
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
Measured: During the procedure known as the simulated home environment visit
Secondary outcomes (3)
Acceptability as measured by the patient satisfaction survey
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.
Measured: Immediately after the procedure known as the stimulated home environment visit
Acceptability as measured by the open ended interview
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)
Measured: Immediately after the procedure known as the stimulated home environment visit
Acceptability as measured by field observations
Study team will capture field notes in REDCap database
Measured: During and immediately after the procedure known as the stimulated home environment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start14 Oct 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Beauchamp, The University of Texas Health Science Center, Houston
- Investigators
- Jennifer E Beauchamp, PhD,RN,FAAN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592627
- Sponsor's protocol ID
- HSC-SN-20-0686
- Status last verified
- Jan 2024
- First submitted
- 7 Oct 2020
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial and Body Motion Technology to Detect Psychosocial Distress in Stroke Survivors and Informal Caregivers Living at Home
- ClinicalTrials.gov ID
- NCT04592627
- Acronym / sponsor ID
- HSC-SN-20-0686
- Conditions
- Stroke
- Keywords
- Stroke, caregiver, technology, psychosocial, aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 19 Oct 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulated home environment visit with the dyad participants | – | Other: Simulated home environment visitThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- stroke survivors currently reside outside of the home and are wheelchair bound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated home environment visitDuring 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. | Other | Simulated home environment visit with the dyad participants |
Primary outcome
Accuracy of the technology
Time frame: During the procedure known as the simulated home environment visit
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
Sensitivity of the technology
Time frame: During the procedure known as the simulated home environment visit
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.
Specificity of the technology
Time frame: During the procedure known as the simulated home environment visit
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
3 secondary outcomes
Acceptability as measured by the patient satisfaction survey
Time frame: Immediately after the procedure known as the stimulated home environment visit
Acceptability as measured by the open ended interview
Time frame: Immediately after the procedure known as the stimulated home environment visit
Acceptability as measured by field observations
Time frame: During and immediately after the procedure known as the stimulated home environment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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.
Jennifer E Beauchamp, PhD,RN,FAAN principal investigator
The University of Texas Health Science Center, Houston
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 Stroke, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of the technology (time frame: During the procedure known as the simulated home environment visit). 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 5 Jan 2024.