RecruitingNot ApplicableNCT06132399

Virtual Reality Software for Patients With Stroke

Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke

Sponsor

Universidad de Almeria

Enrollment

96 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke

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

Min Age: 18 Years

Inclusion Criteria6

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 informed consent

Exclusion Criteria7

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 other unstable condition
A history of cerebrovascular disease (if not fully resolved)
Photosensitive epilepsy

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Interventions

DEVICEMETA QUEST 3 virtual reality glasses

The RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.

DEVICENintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)

This group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games.

OTHERUsual care

The UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.