Mild Cognitive Impairment, Subjective Cognitive Decline (SCD)
Conditions
Keywords
Virtual Reality, Cognitive Rehabilitation, Physical Rehabilitation
Brief summary
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.
Interventions
DEVICEVirtual 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.
Sponsors
The University of Texas Health Science Center, Houston
DPRIT Seed Grant
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Tolerability / Side Effects as assessed by the Simulator Sickness Questionnaire (SSQ) | 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 |
| 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) | 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) | 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. |
| Adherence / Engagement as assessed by the session attendance as entered in VR system logs | Post-intervention only (Final visit at 6 weeks) | — |
Countries
United States
Contacts
CONTACTSeema S Aggarwal, PhD, APRN, AGNP-C
CONTACTTela Todd
PRINCIPAL_INVESTIGATORSeema Aggarwal, PhD, APRN, AGNP-C
The University of Texas Health Science Center, Houston
Outcome results
None listed