Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-90
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Virtual Reality (VR) sessions

    Device

    Participants 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

10 Participants
are divided into 1 treatment group
Group A: Virtual Reality (VR) sessionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility as assessed by the recruitment rate

Time frame
from baseline to end of intervention (6 weeks)
2

Feasibility as assessed by the retention rate

Time frame
from baseline to end of intervention (6 weeks)
3

Feasibility as assessed by the session completion rate

Time frame
from baseline to end of intervention (6 weeks)
4

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.

Time frame
Post-intervention only (Final visit at 6 weeks)

Secondary outcomes

Other outcomes

Sponsors and contacts

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