NCT Number: NCT07125170
This pilot study aims to evaluate the feasibility of implementing immersive virtual reality (VR) in cognitive rehabilitation for adults with post-stroke cognitive impairment receiving outpatient therapy. Participants will use a head-mounted display and interactive software to engage in gamified cognitive exercises that simulate memory, attention, and executive function tasks. The intervention consists of 10 sessions, delivered two to three times per week over a period of approximately four weeks. The study will assess multiple feasibility indicators, including the recruitment rate based on eligibility criteria, the safety and tolerability of VR sessions for participants, and the usability and satisfaction reported by occupational therapists administering the intervention. Additionally, exploratory outcomes include changes in global cognition and specific cognitive domains, as well as self-reported quality of life. Adverse effects related to VR use will be tracked. This pilot study will help inform the design and implementation of future, larger-scale clinical trials.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Independencia, Santiago Metropolitan, Chile
Location status: Recruiting
Diego Elizondo, MD
CONTACT
Diego Elizondo, MD
PRINCIPAL_INVESTIGATOR
Natalia Gattini, MD
CONTACT
Natalia Gattini, MD
PRINCIPAL_INVESTIGATOR
This is a single-arm pilot study designed to evaluate the feasibility of implementing immersive virtual reality (VR) in cognitive rehabilitation for adults with post-stroke cognitive impairment. The study is conducted at the Occupational Therapy Unit of the Hospital Clínico Universidad de Chile and targets adult patients with documented cognitive impairment following a cerebrovascular accident (CVA).
Participants will undergo ten individual VR-assisted cognitive rehabilitation sessions, scheduled at a frequency of two to three sessions per week. Each session lasts approximately one hour, with the first 30 minutes incorporating immersive VR using the Meta Quest 3 headset and the Hand Physics Lab application. This application provides interactive cognitive exercises in a motivating and safe virtual environment. All sessions are supervised by occupational therapists trained in VR therapy.
The study aims to collect feasibility data, including recruitment rates based on inclusion and exclusion criteria, participant adherence to the intervention schedule, and reasons for withdrawal if any. Safety and tolerability will be assessed through patient-reported adverse effects (e.g., dizziness, nausea, or eye strain) using the Simulator Sickness Questionnaire (SSQ). Usability and satisfaction with the VR system will be evaluated from the perspective of the occupational therapists delivering the intervention.
Exploratory outcomes include changes in cognitive function measured with the Montreal Cognitive Assessment (MoCA) and in quality of life using the NeuroQoL short form. These measurements are taken before and after the intervention period. No compensation is provided for participation, and patients continue receiving standard care.
This pilot study does not aim to establish efficacy. Instead, it will provide essential data regarding the feasibility, safety, user experience, and preliminary clinical trends necessary to inform the development of future, larger-scale trials
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive cognitive rehabilitation using immersive virtual reality through the Meta Quest 3 headset and the Kinesix XR application. Each session lasts one hour, with the first 30 minutes involving VR-based tasks guided by an occupational therapist. The intervention consists of a total of ten sessions, delivered two to three times per week. The VR component is integrated into the standard outpatient cognitive rehabilitation program. The study aims to evaluate the feasibility, safety, and acceptability of using this device during therapy.
Time frame: From first session to week 5 (after completion of the 10-session VR program)
Number of participants who complete at least 8 of 10 sessions divided by total enrolled participants.
Time frame: From first session to week 5 (after completion of the 10-session VR program)
Percentage of participants with one or more adverse events related to virtual reality that result in stopping a session, as documented in the patient's clinical record by the occupational therapist. Adverse events include, but are not limited to, nausea, dizziness, headache, and visual fatigue. In addition, symptoms associated with virtual reality will be monitored using the full Spanish-validated version of the Simulator Sickness Questionnaire (SSQ) after sessions 1, 5, and 10. The outcome measure will consider both sources of information -therapist-recorded clinical notes and SSQ scores- to identify and classify safety-related events.
Time frame: At week 5 (after completion of the 10-session VR program)
Therapist-reported usability and satisfaction with the immersive virtual reality intervention, measured using a custom-designed questionnaire rated on a 5-point Likert scale (1 = strongly disagree / very dissatisfied, 5 = strongly agree / very satisfied). The questionnaire includes five statements assessing ease of device setup, ability to personalize VR activities to the patient's cognitive needs, patient motivation during VR sessions, facilitation of active participation through immersion, and overall recommendation of the technology for cognitive rehabilitation. Total scores range from 5 to 25, with higher scores indicating greater usability and satisfaction. The questionnaire will be administered once, at week 5 (after completition of the 10-session VR program)
Time frame: Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program)
Change in the "Montreal Cognitive Assessment (MoCA)" score (range 0-30, higher values indicate better cognitive function). The MoCA is a validated cognitive screening tool designed to detect mild cognitive impairment and assess multiple domains, including visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The Chilean validated version will be administered by a certified occupational therapist at two time points: at baseline (prior to the start of the intervention) and at week 5 (the end of the intervention period). The change will be calculated as the post-intervention score minus the baseline score.
Time frame: Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program)
Change in the "Quality of Life in Neurological Disorders (Neuro-QoL) Cognitive Function Short Form" score (range 8-40, higher scores indicate better self-reported cognitive function and quality of life). The Cognitive Function Short Form is a validated patient-reported outcome measure designed to assess perceived cognitive abilities in adults with neurological conditions. For this study, the validated spanish version will be used. Participants will self-complete the questionnaire at two time points: at baseline (prior to starting the intervention) and at week 5 (after completing the 10-session immersive virtual reality cognitive rehabilitation program). The change will be calculated as the post-intervention score minus the baseline score.
Contact information is provided by the study sponsor or research team.
Diego Elizondo, MD
CONTACT
Natalia Gattini, MD
CONTACT
University of Chile
Other
Immersive Virtual Reality in Cognitive Rehabilitation of Patients With Post-Stroke Cognitive Impairment: A Pilot Study at the Department of Physical Medicine and Rehabilitation, Clinical Hospital of the University of Chile
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