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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 informed consent 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 other unstable condition * A history of cerebrovascular disease (if not fully resolved) * Photosensitive epilepsy

Treatments Being Tested

DEVICE

META 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.

DEVICE

Nintendo 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.

OTHER

Usual 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.

Locations (4)

University of Almería
Almería, Almería, Spain
Torrecárdenas University Hospital
Almería, Spain
San Cecilio University Hospital
Granada, Spain
University of Granada
Granada, Spain