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

Official title

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

Overview

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

Interventions

• Device 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, a

Primary outcome measures

• Proportion of participants who complete ≥80% of planned sessions. [Time frame: From first session to week 5 (after completion of the 10-session VR program)]
• Incidence of VR-related adverse events requiring session interruption [Time frame: 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 [Time frame: At week 5 (after completion of the 10-session VR program)]

Secondary outcome measures (2)

• Change in "Montreal Cognitive Assessment (MoCA)" score [Time frame: 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) [Time frame: Measured at baseline (before the intervention) and at week 5 (after completion of the 10-session VR program)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Chile · 1 center

• Hospital Clinico de la Universidad de Chile — Independencia

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07125170 · 1497/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗