Virtual Reality Software for Patients With Stroke

Official title

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

Overview

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

Detailed 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.

Interventions

• 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.

Primary outcome measures

• Disability (The Barthel index) [Time frame: Changes from baseline to weeks 13 and 26]

Secondary outcome measures (12)

• Quality of life (NEWSQOL) [Time frame: Changes from baseline to weeks 13 and 26]
• Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity) [Time frame: Changes from baseline to weeks 13 and 26]
• Gross manual dexterity (The Box and Block Test) [Time frame: Changes from baseline to weeks 13 and 26]
• Handgrip strength [Time frame: Changes from baseline to weeks 13 and 26]
• Lower extremity function (Berg Balance Scale) [Time frame: Changes from baseline to weeks 13 and 26]
• Lower extremity function (Time Up and Go test) [Time frame: Changes from baseline to weeks 13 and 26]
• Cognitive function [Time frame: Changes from baseline to weeks 13 and 26]
• Cognitive function [Time frame: Changes from baseline to weeks 13 and 26]
• Plasma concentrations of inflammatory markers [Time frame: Changes from baseline to weeks 13 and 26]
• BDNF quantification in blood [Time frame: Changes from baseline to weeks 13 and 26]
• GDNF quantification in blood [Time frame: Changes from baseline to weeks 13 and 26]
• PACAP-38 quantification in blood [Time frame: Changes from baseline to weeks 13 and 26]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 4 centers

• University of Almería — Almería
• Torrecárdenas University Hospital — Almería
• San Cecilio University Hospital — Granada
• University of Granada — Granada

Publications

• Hernandez-Martinez A, Fernandez-Escabias M, Amaya-Pascasio L, Carrilho-Candeias S, Ramos-Teodoro M, Gil-Rodriguez M, Orellana-Jaen A, Martinez-Rosales E, Ruiz-Gonzalez D, Esteban-Simon A, Castro-Ropero B, Del-Olmo-Iruela L, Lopez-Lopez MI, Ramos-Herrera AI, Fajardo-Rodriguez MF, Gomez-Garcia S, Rodriguez-Camacho M, Conde-Negri E, Rodriguez-Perez M, Marcos-Pardo PJ, Ruiz JR, Villegas-Rodriguez I, A PMID 39161559

Identifiers

NCT: NCT06132399 · CPP2021-008497

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗