Facial and Body Motion Technology and Stroke

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT04592627
Collaborator
(none)
12
1
15.5
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulated home environment visit

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

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Facial and Body Motion Technology to Detect Psychosocial Distress in Stroke Survivors and Informal Caregivers Living at Home
Actual Study Start Date :
Oct 14, 2020
Anticipated Primary Completion Date :
Jan 29, 2022
Anticipated Study Completion Date :
Jan 29, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Accuracy of the technology [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

  2. Sensitivity of the technology [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.

  3. Specificity of the technology [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

Secondary Outcome Measures

  1. Acceptability as measured by the patient satisfaction survey [Immediately after the procedure known as the stimulated home environment visit]

    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.

  2. Acceptability as measured by the open ended interview [Immediately after the procedure known as the stimulated home environment visit]

    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)

  3. Acceptability as measured by field observations [During and immediately after the procedure known as the stimulated home environment visit]

    Study team will capture field notes in REDCap database

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Jennifer E Beauchamp, PhD,RN,FAAN, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer E. S. Beauchamp, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT04592627
Other Study ID Numbers:
  • HSC-SN-20-0686
First Posted:
Oct 19, 2020
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer E. S. Beauchamp, Associate Professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2021