Status:
RECRUITING
Virtual Reality Software for Patients With Stroke
Lead Sponsor:
Universidad de Almeria
Collaborating Sponsors:
Ministerio de Ciencia e Innovación, Spain
European Union
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06132399
Start Date
November 15 2024
End Date
November 1 2025
Last Update
November 27 2024
Active Locations (4)
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1
University of Almería
Almería, Almería, Spain, 04120
2
Torrecárdenas University Hospital
Almería, Spain, 04009
3
San Cecilio University Hospital
Granada, Spain, 18016
4
University of Granada
Granada, Spain, 18071