Virtual Reality Software for Patients With Stroke (RESET)

Universidad de Almeria

Status: Enrolling

Conditions: Stroke

Treatments: Device: META QUEST 3 virtual reality glasses; Other: Usual care; Device: Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)

Study type: Interventional

Funder types: Other

Identifiers

NCT06132399

CPP2021-008497

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups

Commercial non-immersive virtual reality group (CVR)

Active Comparator group

Description:

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

Treatment:

Device: Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)

Gamified, fully immersive and stroke-specific virtual reality group (RESET)

Experimental group

Description:

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

Treatment:

Device: META QUEST 3 virtual reality glasses

Usual care (UC)

Active Comparator group

Description:

3 session/week of 90 minutes of physical therapy and occupational therapy.

Treatment:

Other: Usual care