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

June 9, 2026 updated by: Seema S Aggarwal, The University of Texas Health Science Center, Houston

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

The purpose of this study is to demonstrate feasibility, usability, and acceptability of 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR sessions
Device: VR sessions
Participants will complete 3 supervised VR sessions using the Real System™ VR headset, per week for 6 weeks, for a total of 18 sessions. Each session will last approximately 60 minutes, with time allocated for setup and brief symptom checks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as assessed by the recruitment rate
Time Frame: from baseline to end of intervention (6 weeks)
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)
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)
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.
Post-intervention only (Final visit at 6 weeks)
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.
Post-intervention only (Final visit at 6 weeks)
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
Before + immediately After each VR session
Adherence / Engagement as assessed by the session attendance as entered in VR system logs
Time Frame: Post-intervention only (Final visit at 6 weeks)
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)
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)
Post-intervention only (Final visit at 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

DPRIT Seed Grant

Investigators

  • Principal Investigator: Seema Aggarwal, PhD, APRN, AGNP-C, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 12, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-26-0038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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