Virtual reality software to help stroke patients
Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke
This study is testing a new virtual reality program to see if it can help stroke patients recover better than regular rehab or other VR options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Almeria Academic / other |
| Locations | 4 sites (Almería, Almería and 3 other locations) |
| Trial ID | NCT06132399 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop and validate a gamified, fully immersive virtual reality software specifically designed for stroke patients. The intervention will be tested over a 10-week period, comparing its effects on physical disability and quality of life against usual care rehabilitation and a commercially available VR system. The study will assess various outcomes, including upper-body motor function, manual dexterity, handgrip strength, balance, and cognitive function. By integrating virtual reality into rehabilitation, the trial seeks to enhance the recovery process for individuals affected by stroke.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced an ischemic or hemorrhagic stroke within the last 7 to 14 days and have some level of motor function impairment.
Not a fit: Patients with severe cognitive impairments, significant behavioral issues, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve rehabilitation outcomes and quality of life for stroke patients.
How similar studies have performed: While virtual reality has shown promise in neurological rehabilitation, this specific approach targeting stroke patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Almería, Almería and 3 other locations
- University of Almería — Almería, Almería, Spain (Recruiting)
- Torrecárdenas University Hospital — Almería, Spain (Recruiting)
- San Cecilio University Hospital — Granada, Spain (Recruiting)
- University of Granada — Granada, Spain (Recruiting)
Study contacts
- Principal investigator: Alberto Soriano-Maldonado, PhD — Universidad de Almeria
- Study coordinator: Alberto Soriano-Maldonado, PhD
- Email: asoriano@ual.es
- Phone: 950 01 55 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.