Facial and Body Motion Technology and Stroke

NCT ID: NCT04592627

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Simulated home environment visit

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jennifer Beauchamp

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer E Beauchamp, PhD,RN,FAAN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-SN-20-0686

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tACS for Sensory Motor Recovery After Stroke
NCT06029062 NOT_YET_RECRUITING NA
Fast Arm Motor Skill Training
NCT05013762 COMPLETED NA
Mindfulness After Stroke
NCT04553679 COMPLETED
Emotional Recovery Post-Stroke
NCT06782321 RECRUITING NA