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Not yet recruiting NCT07638748

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

No phase Interventional Mild Cognitive Impairment Subjective Cognitive Decline (SCD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR sessions.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Subjective Cognitive Decline (SCD). Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • 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)]
  • Acceptability / Presence as assessed by the Presence Questionnaire (PQ) [Time frame: 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]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07638748 · HSC-MS-26-0038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗