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IVR ON UPPER-LIMB REHABILITATION IN STROKE PATIENTS: A CLINICAL TRIAL

NCT07609966 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-27

No results posted yet for this study

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. 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

Conditions

  • Stroke Acute

Interventions

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.

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2025-11-29
Completion
2026-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609966 on ClinicalTrials.gov