Virtual Reality Software for Patients With Stroke

Last updated: November 25, 2024
Sponsor: Universidad de Almeria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

META QUEST 3 virtual reality glasses

VIRTUAL REALITY GLASSES

Usual care

Clinical Study ID

NCT06132399
CPP2021-008497
  • Ages > 18
  • All Genders

Study Summary

The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke.

The main questions it aims to answer are:

  • To assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available VR system, on disability in patients with stroke.

  • To assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women and men with either an ischemic or hemorrhagic stroke

  • Stroke between the last 7 to 14 days

  • Functional independence before stroke (modified Rankin scale <3)

  • Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the National Institutes of Health Stroke Scale (NIHSS) scale

  • Trunk control in seated and standing position

  • Ability to understand basic instructions and to decide whether to sign informedconsent

Exclusion

Exclusion Criteria:

  • Moderate-severe aphasia that precludes understanding the required tasks

  • Cognitive impairment that precludes cooperation with tasks

  • Serious behavioral problems or mental disorders

  • Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases,lower limb fractures, or recent myocardial infarction

  • Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or otherunstable condition

  • A history of cerebrovascular disease (if not fully resolved)

  • Photosensitive epilepsy

Study Design

Total Participants: 96
Treatment Group(s): 4
Primary Treatment: META QUEST 3 virtual reality glasses
Phase:
Study Start date:
November 15, 2024
Estimated Completion Date:
November 30, 2025

Study Description

Stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide. According to data from the World Health Organization, since 2005, the global probability of a person experiencing a stroke has increased by 50 percent. It is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime. A stroke can result in significant loss of motor functions, communications abilities, weakness, or hemiparesis, leading to a diminished quality of life. Therefore, improving the rehabilitation process is evidently of paramount significance. Virtual reality has emerged as a novel strategy to improve neurological diseases; however, there is an absence of an immersive software designed specifically for stroke patients within a gamified environment. Therefore, the aim of RESET randomized controlled trial is to evaluate the effect of a gamified, fully immersive, and stroke-specific virtual reality software on disability in stroke patients.

Connect with a study center

  • University of Almería

    Almeria, Almería 04120
    Spain

    Active - Recruiting

  • Torrecárdenas University Hospital

    Almeria, 04009
    Spain

    Active - Recruiting

  • San Cecilio University Hospital

    Granada, 18016
    Spain

    Active - Recruiting

  • University of Granada

    Granada, 18071
    Spain

    Active - Recruiting

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