Immersive Virtual Reality in Cognitive Rehabilitation of Patients With Post-Stroke Cognitive Impairment

NCT07125170 | Recruiting

• 1 other identifier: 1497/25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Post-Stroke Cognitive Impairment (PSCI); Cognitive Dysfunction; Virtual Reality Therapy; Virtual Reality Cognitive Training; Cognitive Rehabilitation

Keywords

virtual reality; Cognitive rehabilitation; Immersive Therapy; Meta Quest 3; Kinesix XR; Occupational Therapy; Montreal Cognitive Assessment (MoCA); Simulator Sickness Questionnaire (SSQ)

Outcome Measures

Primary Outcomes (3)

• 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.

  From first session to week 5 (after completion of the 10-session VR program)

• 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.

  From first session to week 5 (after completion of the 10-session VR program)

• 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)

  At week 5 (after completion of the 10-session VR program)

Secondary Outcomes (2)

• Change in "Montreal Cognitive Assessment (MoCA)" score

  Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program)

• Change in quality of life measured by NeuroQoL (Cognitive Function Short Form)

  Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program)

Study Arms (1)

VR-based Cognitive Rehabilitation

EXPERIMENTAL

Participants receive cognitive rehabilitation supported by immersive virtual reality using the Meta Quest 3 headset and the Kinesix XR application. Each session lasts 60 minutes, with the first 30 minutes involving VR-based cognitive tasks supervised by an occupational therapist. A total of ten sessions are completed over a period of approximately four weeks, with a frequency of two to three sessions per week. This arm is designed to assess the feasibility, safety, usability, and preliminary effects of VR-assisted rehabilitation in patients with post-stroke cognitive impairment.

Device: Kinesix XR on Meta Quest 3

Interventions

Kinesix XR on Meta Quest 3 DEVICE

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.

VR-based Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Referred for cognitive rehabilitation at the Occupational Therapy Unit of HCUCH

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clinico de la Universidad de Chile

Independencia, Santiago Metropolitan, Chile

RECRUITING

Related Publications (3)

• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

  PMID: 29156493 BACKGROUND

• Pallesen H, Andersen MB, Hansen GM, Lundquist CB, Brunner I. Patients' and Health Professionals' Experiences of Using Virtual Reality Technology for Upper Limb Training after Stroke: A Qualitative Substudy. Rehabil Res Pract. 2018 Feb 8;2018:4318678. doi: 10.1155/2018/4318678. eCollection 2018.

  PMID: 29593910 BACKGROUND

• Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.

  PMID: 21440699 BACKGROUND

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Natalia Gattini, MD

CONTACT

+56989019110; ngattini@hcuch.cl

Diego Elizondo, MD

CONTACT

+56951087567; diegoelizondo@ug.uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant professor

Model Details: This is a pilot, prospective, interventional, uncontrolled clinical study with a single assigned group. All participants will receive immersive virtual reality cognitive rehabilitation (Meta Quest 3, Kinesix XR application) for 30 minutes at the start of each occupational therapy session, followed by 30 minutes of conventional cognitive rehabilitation. Each participant will complete 10 sessions over an approximate period of 4 to 5 weeks. The study model is designed to assess the feasibility, safety, usability, and satisfaction of using immersive virtual reality in patients with post-stroke cognitive impairment, as well as its preliminary impact on cognitive function and quality of life.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 15, 2025
• Study Start: August 6, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)