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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Torrecárdenas University Hospital
RECRUITING
Almería
University of Almería
RECRUITING
Almería
San Cecilio University Hospital
RECRUITING
Granada
University of Granada
RECRUITING
Granada
Contact Information
Primary
Alberto Soriano-Maldonado, PhD
asoriano@ual.es
950 01 55 50
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2025-11
Participants
Target number of participants: 96
Treatments
Active_comparator: Commercial non-immersive virtual reality group (CVR)
Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan).
Experimental: Gamified, fully immersive and stroke-specific virtual reality group (RESET)
The RESET virtual reality software will be integrated in the META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US).
Active_comparator: Usual care (UC)
3 session/week of 90 minutes of physical therapy and occupational therapy.
Related Therapeutic Areas
Sponsors
Collaborators: Ministerio de Ciencia e Innovación, Spain, European Union
Leads: Universidad de Almeria

This content was sourced from clinicaltrials.gov