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.
Patients over 18 years of age
Patients with a cerebrovascular accident of any etiology with less than 3 months of progression
Patients with mild to moderate cognitive impairment post-stroke (impairment in at least one cognitive domain)
MoCA score of less than 24 points
Patients with refractive errors that prevent the use of the headset
Patients with any type of aphasia that prevents the administration of the MoCA test
Patients with severe psychiatric disorders (presence of psychotic symptoms or derealization)
Patients with severe motor impairments (lack of trunk control or global strength of both upper limbs < M3)
Single group
Kinesix XR on Meta Quest 3
DeviceParticipants 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.
Proportion of participants who complete ≥80% of planned sessions.
Number of participants who complete at least 8 of 10 sessions divided by total enrolled participants.
Incidence of VR-related adverse events requiring session interruption
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.
Therapist-reported usability and satisfaction with immersive virtual reality in cognitive rehabilitation
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)
Change in "Montreal Cognitive Assessment (MoCA)" score
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.
Change in quality of life measured by NeuroQoL (Cognitive Function Short Form)
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.
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