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NCT Number: NCT07638748

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Subjective Cognitive Decline (SCD)

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ambulatory

Exclusion criteria

  • 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.)
  • Any condition that the research team determines would interfere with safe participation

Treatment and study plan

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.

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)

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

    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.

  5. Acceptability / Presence as assessed by the Presence Questionnaire (PQ)

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

    This is a 29 item questionnaire, each is scored on a seven-point Likert-type scale with a score range form 29-203. Higher scores indicate a greater sense of presence or immersion in the virtual environment.

  6. Tolerability / Side Effects as assessed by the Simulator Sickness Questionnaire (SSQ)

    Time frame: Before + immediately After each VR session

    This is a 16 item questionnaire and each is scored form 0(none) to 3(severe). Scores are combined using weighted subscales to generate a total score, with higher scores indicating greater simulator sickness

  7. Adherence / Engagement as assessed by the session attendance as entered in VR system logs

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

  8. Adherence / Engagement as assessed by the time from start to end of VR session as entered in VR system logs

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

  9. Adherence / Engagement as assessed by the number of repetitions of the activity as indicated by device metrics

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • DPRIT Seed Grant

Registry information

Official study title

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

Acronym: (VR-MCI)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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