Clinical trial NCT06132399: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
name: European Union
First posted: 2023-11-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Disability (The Barthel index)
timeFrame: Changes from baseline to weeks 13 and 26
Secondary outcomes:
measure: Quality of life (NEWSQOL)
timeFrame: Changes from baseline to weeks 13 and 26
measure: Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity)
timeFrame: Changes from baseline to weeks 13 and 26
measure: Gross manual dexterity (The Box and Block Test)
timeFrame: Changes from baseline to weeks 13 and 26
measure: Handgrip strength
timeFrame: Changes from baseline to weeks 13 and 26
measure: Lower extremity function (Berg Balance Scale)
timeFrame: Changes from baseline to weeks 13 and 26
measure: Lower extremity function (Time Up and Go test)
timeFrame: Changes from baseline to weeks 13 and 26
measure: Cognitive function
timeFrame: Changes from baseline to weeks 13 and 26
measure: Cognitive function
timeFrame: Changes from baseline to weeks 13 and 26
measure: Plasma concentrations of inflammatory markers
timeFrame: Changes from baseline to weeks 13 and 26
measure: BDNF quantification in blood
timeFrame: Changes from baseline to weeks 13 and 26
measure: GDNF quantification in blood
timeFrame: Changes from baseline to weeks 13 and 26
measure: PACAP-38 quantification in blood
timeFrame: Changes from baseline to weeks 13 and 26
measure: Plasma concentrations of inflammatory markers, quantification in blood
timeFrame: Changes from baseline to weeks 13 and 26
measure: IGF-1 quantification in blood
timeFrame: Changes from baseline to weeks 13 and 26
measure: NGF quantification in blood
timeFrame: Changes from baseline to weeks 13 and 26
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: University of Almería
state: Almería
city: Almeria
country: Spain
facility: Torrecárdenas University Hospital
city: Granada
country: Spain
facility: San Cecilio University Hospital
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Almeria
name: Alberto Soriano-Maldonado, PhD
role: PRINCIPAL_INVESTIGATOR
References: