An interventional study of Immersive Virtual Reality in Stroke Acute, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Not applicable, Interventional, and Treatment
Stroke is the leading cause of acquired disability in adults. Neurorehabilitation aims to recover the affected function by stimulating neuroplasticity. Immersive virtual reality (IVR) has shown that it can be effective but the evidence is still weak. Similarly, few studies have analysed blood biomarkers as outcome or predictive indicators, and knowledge of the influence of genetic polymorphisms on rehabilitation efficacy is limited. Our objectives are (1) to demonstrate that the addition of IVR to conventional rehabilitation (CR) improves upper-limb motor function, functional status, and quality of life in stroke patients, at short and long term; (2) to determine the effect of IVR on the expression of neuroplasticity biomarkers at long term; (3) to evaluate the impact of genetic polymorphisms on the rehabilitation and functional prognosis of treated patients, at short and long term; and (4) to identify acute phase predictive biomarkers of motor recovery and functional prognosis at short and long term. To this end, we propose a single-center, prospective, randomised, controlled, and open label clinical trial with blinded end-point assessment. Adults diagnosed of acute ischaemic/haemorrhagic stroke with mobility impaired in the upper-limb and included in a program of intensive CR (ICR) at hospital discharge will be included. Patients will be randomly assigned into two groups: ICR+IVR or only ICR and will be followed for one year to assess, at 3 and 12 months, motor strength in the upper-limb, functional dependence and quality of life. In blood samples obtained at admission (baseline) and at 12 months, proteins and microRNAs will be analysed to identify predictive biomarkers of recovery (motor and functional) and to determine the effect of IVR on neuroplasticity mechanisms. Genetic polymorphisms that may affect motor and functional recovery of patients treated with RC±RVI will also be analysed
The study will be conducted as a single-center, prospective, randomized, controlled, open-label clinical trial with blinded endpoint assessment. It aims to evaluate the benefits of neurorehabilitation combining conventional rehabilitation (CR) and immersive virtual reality (IVR) on patients' motor function and functional prognosis, as well as on the expression of blood biomarkers of neuroplasticity and the influence of specific genetic polymorphisms on rehabilitation response.
2. Study population
All patients meeting the following criteria will be included:
Inclusion criteria Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. \< 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
Patients eligible for participation in the study will be those admitted to the Stroke Unit of Dr. Josep Trueta University Hospital (HUJT) with a diagnosis of ischemic stroke or intracerebral hemorrhage. Following clinical stabilization, and always within the first seven days after stroke onset, inclusion and exclusion criteria will be reviewed. Patients and their relatives will be informed about the study and will sign the informed consent forms (study and biobank). Patients will then be randomly assigned to one of the two study groups in a 1:1 ratio using a web-based platform and will be assigned an identification number for pseudonymization purposes.
The study groups will be:
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. \< 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study form (ICF) and the IDIBGI Biobank informed consent form.
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Exclusion Criteria:
Previous upper limb disability (neurological or non-neurological cause). Previous dementia or any disease with a of less than 1 year. Language comprehension difficulties. Difficulty remembering exercise instructions. History of photosensitive epilepsy.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
Other: Immersive Virtual Reality
patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
Also known as: IVR Group, Control Group
Motor Function
NIHSS assessment of arm function
Time frame: at 3 and 12 months
Quality of life of patients
ECVI-38
Time frame: 3 and 12 months
Functional outcome
modified Rankin scale
Time frame: 3 and 12 months
FAC
Assessment of FAC
Time frame: 3 and 12 months
Fugl-Meyer
Fugl-Meyer Assessment
Time frame: 3 and 12 months
BBT
Assessment of BBT (Box and Block Test)
Time frame: 3 and 12 months
9HPT
Assessment of 9HPT (Nine-Hole Peg Test)
Time frame: 3 and 12 months
Safety measure
Adverse events
Time frame: 3 months
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta