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NCT06132399Recruiting

Virtual Reality Software for Patients With Stroke

Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke

Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
96 (estimated)
First submitted
26 Oct 2023
Start date
15 Nov 2024
Primary completion date
Aug 2025
Lead sponsor
Universidad de Almeria
Diseases
Stroke
NCT number
NCT06132399

What you commit to

  • Study type: Interventional
  • Planned participants: 96
  • From 15 Nov 2024 to the primary completion date, Aug 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Moderate-severe aphasia that precludes understanding the required tasks

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Almeria
Coordinator of this site? Confirm its status
AlmeríaSpainRecruiting
Torrecárdenas University Hospital
Coordinator of this site? Confirm its status
AlmeríaSpainRecruiting
University of Granada
Coordinator of this site? Confirm its status
GranadaSpainRecruiting
San Cecilio University Hospital
Coordinator of this site? Confirm its status
GranadaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.