Learning in a Virtual Environment (LIVE) for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Stroke
Learning in a Virtual Environment (LIVE) - Behavioral
Eligibility
18+
All Sexes
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Study Summary

This trial is to test a new virtual reality intervention specifically for stroke survivors and caregivers that includes real-time education and social interaction. They want to see if it is feasible and acceptable to participants, and if it can be used to generate hypotheses for a larger trial to show treatment efficacy. The Learning in a Virtual Environment (LIVE) treatment is being trialed to see if it is effective in treating Stroke. This treatment has been approved by the FDA for a different condition in the past. There will be no patients in this trial that receive a placebo.

Treatment Effectiveness

Study Objectives

9 Primary · 10 Secondary · Reporting Duration: post intervention (8 weeks from baseline)

Week 8
Change in ability to recover form stress as measured by the Brief Resilience Scale
Change in anxiety as assessed by the Generalized Anxiety Disorder-7 score
Change in caregiver burden as assessed by the Zarit Burden Interview (ZBI)
Change in emotional support as assessed by the NIH Emotional Support Form
Change in instrumental support as assessed by the PROMIS Short Form v2.0
Change in loneliness as assessed by the UCLA loneliness scale scores
Change in perceived social support as assessed by the Multidimensional Scale of Perceived Social Support (MSPSS)
Change in post stroke depression as assessed by the Patient Health Questionnaire-9 score (PHQ-9)
Change in self efficacy ( ability to perform tasks or behaviors) as assessed by the PROMIS General Self-efficacy Form
Change in the amount that pain interferes with daily life as assessed by the PROMIS Short Form Pain Interference v 1.0 8a
Week 8
Acceptability as assessed by the number of VE objects manipulated
Week 8
Feasibility as assessed by the number of participants enrolled in the study
Feasibility as assessed by the number of participants who complete the data collection forms
Feasibility as assessed by the number of participants who complete the study
Week 8
Acceptability as assessed by the number of VE Meetings attended
Usability as assessed by the number of times the participants log in
Usability as assessed by the perceived ease of use scores
Usability as assessed by the perceived usefulness score
Usability as assessed by the time spent in the environment in minutes

Trial Safety

Trial Design

1 Treatment Group

Treatment
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Learning in a Virtual Environment (LIVE) · No Placebo Group · N/A

Treatment
Behavioral
Experimental Group · 1 Intervention: Learning in a Virtual Environment (LIVE) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post intervention (8 weeks from baseline)
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2007First Recorded Clinical Trial
9 TrialsResearching Stroke
189 CompletedClinical Trials

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
786 Previous Clinical Trials
245,663 Total Patients Enrolled
33 Trials studying Stroke
6,360 Patients Enrolled for Stroke
Jennifer Beauchamp, PhD, RNPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to provide written consent.\n
You have used a computer for ≥1 month.
You understand how to use the Internet.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.