NCT06132399 Virtual Reality Software for Patients With Stroke
| NCT ID | NCT06132399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Almeria |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2024-11-15 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Alberto Soriano-Maldonado, PhD
PRINCIPAL INVESTIGATOR
Universidad de Almeria
Frequently Asked Questions
Who can join the NCT06132399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06132399 currently recruiting?
Yes, NCT06132399 is actively recruiting participants. Contact the research team at asoriano@ual.es for enrollment information.
Where is the NCT06132399 trial being conducted?
This trial is being conducted at Almería, Spain, Almería, Spain, Granada, Spain, Granada, Spain.
Who is sponsoring the NCT06132399 clinical trial?
NCT06132399 is sponsored by Universidad de Almeria. The principal investigator is Alberto Soriano-Maldonado, PhD at Universidad de Almeria. The trial plans to enroll 96 participants.
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