AzTrials
AzTrials

StrokeNCT07125170

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

A study testing Kinesix XR on Meta Quest 3 in people with Stroke and Post-Stroke Cognitive Impairment (PSCI), run by University of Chile at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Kinesix XR on Meta Quest 3
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChile
Study dates
6 Aug 2025to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Natalia Gattini, MD contact

+56989019110

ngattini@hcuch.cl

Diego Elizondo, MD contact

+56951087567

diegoelizondo@ug.uchile.cl

Chile1 site, 1 recruiting

  • Hospital Clinico de la Universidad de Chile

    Independencia, Santiago Metropolitan

    Natalia Gattini, MD, +56989019110, ngattini@hcuch.cl

    Diego Elizondo, MD, +56951087567, diegoelizondo@ug.uchile.cl

    Recruiting

Other trials in Chile

About this study

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

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.

Read the 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

Being tested
Kinesix XR on Meta Quest 3
Keywords
virtual reality, Cognitive rehabilitation, Immersive Therapy, Meta Quest 3, Kinesix XR, Occupational Therapy, Montreal Cognitive Assessment (MoCA), Simulator Sickness Questionnaire (SSQ)
Medical subject headings
Stroke, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesix XR on Meta Quest 3Device

    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.

Study groups in NCT07125170
Study groupRoleWhat they receive
VR-based Cognitive RehabilitationExperimentalParticipants 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.
Receives: Device: Kinesix XR on Meta Quest 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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)

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

Secondary outcomes (2)

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start6 Aug 2025
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07125170
Sponsor's protocol ID
1497/25
Status last verified
Aug 2025
First submitted
29 Jul 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 21440699

Questions about this trial

What is this clinical trial studying?

A study testing Kinesix XR on Meta Quest 3 in people with Stroke and Post-Stroke Cognitive Impairment (PSCI), run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalia Gattini, MD (+56989019110, ngattini@hcuch.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07125170, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in