Facial and Body Motion Technology and Stroke

Stroke Clinical Trial

Official title:

Facial and Body Motion Technology to Detect Psychosocial Distress in Stroke Survivors and Informal Caregivers Living at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592627
• Other study ID #: HSC-SN-20-0686
• Status: Completed
• Start date: October 14, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Simulated home environment visit
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the procedure known as the simulated home environment visit
Primary	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.	During the procedure known as the simulated home environment visit
Primary	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	During the procedure known as the simulated home environment visit
Secondary	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.	Immediately after the procedure known as the stimulated home environment visit
Secondary	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)	Immediately after the procedure known as the stimulated home environment visit
Secondary	Acceptability as measured by field observations	Study team will capture field notes in REDCap database	During and immediately after the procedure known as the stimulated home environment visit