NCT07638748

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

June 2, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

June 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 2, 2026

Last Update Submit

June 9, 2026

Conditions

Mild Cognitive ImpairmentSubjective Cognitive Decline (SCD)

Keywords

Virtual RealityCognitive RehabilitationPhysical Rehabilitation

Outcome Measures

Primary Outcomes (9)

  • Feasibility as assessed by the recruitment rate

    from baseline to end of intervention (6 weeks)

  • Feasibility as assessed by the retention rate

    from baseline to end of intervention (6 weeks)

  • Feasibility as assessed by the session completion rate

    from baseline to end of intervention (6 weeks)

  • 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.

    Post-intervention only (Final visit at 6 weeks)

  • Acceptability / Presence as assessed by the Presence Questionnaire (PQ)

    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)

    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

    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

    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

    Post-intervention only (Final visit at 6 weeks)

Study Arms (1)

VR sessions

EXPERIMENTAL
Device: VR sessions

Interventions

VR sessionsDEVICE

Participants will complete 3 supervised VR sessions using the Real Systemâ„¢ 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

VR sessions

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Seema Aggarwal, PhD, APRN, AGNP-C

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seema S Aggarwal, PhD, APRN, AGNP-C

CONTACT

(713) 500-9946Seema.S.Aggarwal@uth.tmc.edu

Tela Todd

CONTACT

(713) 500-7039Tela.Todd@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 10, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)