Stroke AcuteREVICTUSNCT07609966
IVR ON UPPER-LIMB REHABILITATION IN STROKE PATIENTS: A CLINICAL TRIAL
A study testing Immersive Virtual Reality in people with Stroke Acute, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- Immersive Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2022to Jun 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
None listed.
Who cannot join
- Previous upper limb disability (neurological or non-neurological cause). Previous dementia or any disease with a life expectancy of less than 1 year. Language comprehension difficulties. Difficulty remembering exercise instructions. History of photosensitive epilepsy.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Dr Josep Trueta
Girona
Yolanda Silva, MD PhD, 34972940262, neurologia.girona.ics@gencat.cat
Mikel Terceño, MD PhD
About this study
Official title: Impact of Immersive Virtual Reality in the Rehabilitation in the Acute Phase of Stroke: a Clinical Study and Correlation With Blood Biomarkers and Polymorphisms Related to Neuroplasticity
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
Read the detailed description
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.
- 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.
- Conditions
- Stroke Acute
- Being tested
- Immersive Virtual Reality
- Keywords
- stroke, virtual reality, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityOther
Also called IVR Group, Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| IVR group | Active comparator | 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. Receives: Other: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function
NIHSS assessment of arm function
Measured: at 3 and 12 months
Quality of life of patients
ECVI-38
Measured: 3 and 12 months
Functional outcome
modified Rankin scale
Measured: 3 and 12 months
Secondary outcomes (5)
FAC
Assessment of FAC
Measured: 3 and 12 months
Fugl-Meyer
Fugl-Meyer Assessment
Measured: 3 and 12 months
BBT
Assessment of BBT (Box and Block Test)
Measured: 3 and 12 months
9HPT
Assessment of 9HPT (Nine-Hole Peg Test)
Measured: 3 and 12 months
Safety measure
Adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start31 Aug 2022
- Primary completion29 Nov 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609966
- Sponsor's protocol ID
- 2024.085
- Other IDs
- PI24/00008
- Acronym
- REVICTUS
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immersive Virtual Reality in the Rehabilitation in the Acute Phase of Stroke: a Clinical Study and Correlation With Blood Biomarkers and Polymorphisms Related to Neuroplasticity
- ClinicalTrials.gov ID
- NCT07609966
- Acronym / sponsor ID
- REVICTUS / 2024.085
- Conditions
- Stroke Acute
- Keywords
- stroke, virtual reality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 29 Nov 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| IVR group | Active comparator | Other: Immersive Virtual RealityIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Previous upper limb disability (neurological or non-neurological cause). Previous dementia or any disease with a life expectancy of less than 1 year. Language comprehension difficulties. Difficulty remembering exercise instructions. History of photosensitive epilepsy.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityAlso: IVR Group, Control Grouppatients 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 | IVR group |
Primary outcome
Motor Function
Time frame: at 3 and 12 months
NIHSS assessment of arm function
Quality of life of patients
Time frame: 3 and 12 months
ECVI-38
Functional outcome
Time frame: 3 and 12 months
modified Rankin scale
5 secondary outcomes
FAC
Time frame: 3 and 12 months
Fugl-Meyer
Time frame: 3 and 12 months
BBT
Time frame: 3 and 12 months
9HPT
Time frame: 3 and 12 months
Safety measure
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 29156493Laver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Stroke Acute, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
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 0 inclusion and 2 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 27 May 2026. 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 Spain. 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 Yolanda Silva, MD PhD (34972940262, ysilva.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Function (time frame: at 3 and 12 months). 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 NCT07609966, which also lists 1 linked publication.
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 27 May 2026.