Virtual Reality Software for Patients With Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Almeria
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- META QUEST 3 virtual reality glasses
- Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)
- Usual care
Treatment groups
96 Participants
are divided into 3 treatment groupsSponsors and collaborators
Universidad de Almeria
Lead sponsor
Ministerio de Ciencia e Innovación, Spain
Collaborator
European Union
Collaborator
Source ClinicalTrials.gov