NCT Number: NCT07609966
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Girona, Spain
Location status: Recruiting
Carme Gubern
SUB_INVESTIGATOR
Elisabet Ortiz
SUB_INVESTIGATOR
Elisvan Rufino
SUB_INVESTIGATOR
Imma Boada
SUB_INVESTIGATOR
Mikel Terceño, MD PhD
SUB_INVESTIGATOR
Nuria Bas
SUB_INVESTIGATOR
Yolanda Silva, MD PhD
CONTACT
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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Exclusion criteria
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.
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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 names: IVR Group, Control Group
Time frame: at 3 and 12 months
NIHSS assessment of arm function
Time frame: 3 and 12 months
ECVI-38
Time frame: 3 and 12 months
modified Rankin scale
Time frame: 3 and 12 months
Assessment of FAC
Time frame: 3 and 12 months
Fugl-Meyer Assessment
Time frame: 3 and 12 months
Assessment of BBT (Box and Block Test)
Time frame: 3 and 12 months
Assessment of 9HPT (Nine-Hole Peg Test)
Time frame: 3 months
Adverse events
Contact information is provided by the study sponsor or research team.
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Other
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
Acronym: REVICTUS
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