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

DEVICE

Virtual Reality (VR) sessions

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.

Feasibility as assessed by the recruitment rate

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

Feasibility as assessed by the retention rate

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

Feasibility as assessed by the session completion rate

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

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.

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.

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

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

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

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)

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)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.