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

NCT ID: NCT07125170

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-06
• Study Completion Date: 2026-05-01

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.

Detailed Description

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VR-based Cognitive Rehabilitation

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.

Group Type: EXPERIMENTAL

Kinesix XR on Meta Quest 3

Intervention Type: 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.

Interventions

Kinesix XR on Meta Quest 3

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Natalia Gattini

Asistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinico de la Universidad de Chile

Independencia, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Natalia Gattini, MD

Role: CONTACT

ngattini@hcuch.cl

+56989019110

Diego Elizondo, MD

Role: CONTACT

diegoelizondo@ug.uchile.cl

+56951087567

Facility Contacts

Natalia Gattini, MD

Role: primary

ngattini@hcuch.cl

+56989019110

Diego Elizondo, MD

Role: backup

diegoelizondo@ug.uchile.cl

+56951087567

References

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.

Reference Type: BACKGROUND

PMID: 29156493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29593910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21440699 (View on PubMed)

Other Identifiers

1497/25

Identifier Type: -

Identifier Source: org_study_id