About this trial
The purpose of this study is to demonstrate feasibility, usability, and acceptability of virtual reality (VR)-based cognitive and physical rehabilitation, evaluate adherence, tolerability, and fidelity to the VR intervention and explore preliminary effectiveness of VR-based rehabilitation on cognitive, physical, and functional outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of MCI (MoCA 18-26) or self-reported subjective cognitive decline (SCD)
Capacity to provide informed consent
Able to provide own transportation to sessions
Speaks and understands English
Disqualifiers
Uncontrolled seizures or epilepsy
Severe psychiatric illness or active suicidality
Inability to follow instructions or tolerate VR (severe motion sickness)
Cognitive impairment as a result of a known cause (e.g., dementia, stroke, Traumatic Brain Injury (TBI), medications, etc.)
Trial design
Single group
Treatments tested in this trial
Virtual Reality (VR) sessions
DeviceParticipants will complete 3 supervised virtual reality (VR) sessions per week for 6 weeks for a total of 18 sessions using either the Real System VR headset or the Oculus Quest 2 VR headset. Each session will last approximately 60 minutes, with time allocated for setup and brief symptom checks.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility as assessed by the recruitment rate
Feasibility as assessed by the retention rate
Feasibility as assessed by the session completion rate
Usability as assessed by the System Usability Scale (SUS)
The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess participants' perceived usability of the intervention. each rated on a 5-point Likert scale from 1 = Strongly Disagree, 2 = Disagree 3 = Neutral ,4 = Agree, 5 = Strongly Agree. Scores range from 0 to 100, with higher scores indicating greater usability.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
DPRIT Seed Grant
Collaborator