An interventional study of Immersive Virtual Reality with Head Mounted Display and Aerobic exercise and strength training in People With Dependency, sponsored by Universidad de Almeria. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
The project explores the use of virtual reality (VR) as a tool to improve the quality of life of people with dependence, providing immersive and personalized environments that support physical, neurological and psychological rehabilitation. VR makes it possible to practice complex movements, improve strength and coordination, reduce stress and anxiety, and enhance brain plasticity through adapted simulations that are also motivating and safe for users. This approach facilitates more effective rehabilitation than traditional therapies by allowing repetition and visualization of movements that are difficult to perform in real life. The El Saliente Association, in collaboration with the University of Almeria, leads this initiative that seeks to promote the autonomy, inclusion and emotional well-being of people with dependence. With specific objectives such as improving motor function, stimulating neuroplasticity, reducing pain through immersive distraction and enhancing independence, the project uses VR sessions in controlled environments. In addition, activities that simulate everyday situations will be designed to facilitate the transfer of acquired skills to the real environment. The work plan is divided into design, development, implementation and analysis phases, including participant selection, software development, pilot testing and evaluation of results. At each stage, data will be collected to measure the effectiveness of the intervention, with the ultimate goal of publishing the findings in scientific forums and replicating the experience in other contexts. Day center facilities and a residential complex will provide the necessary spaces and materials to carry out the interventions. Expected outcomes include increased motivation and adherence to therapy, faster functional recovery and an overall improvement in quality of life, including increased self-esteem and reduced anxiety. This project promises a significant advance in the use of technology for inclusive rehabilitation, with benefits not only for patients but also for the advancement of innovative therapeutic solutions in the field of dependency.
The world's population is aging rapidly. Globally, the number of people aged 80 years and older is projected to more than triple between 2017 and 2050, from 137 million to 425 million (1). Various studies have shown that the four most common health conditions in older adults are decreased motor skills, increased obesity, cognitive impairment, and psychological disorders, leading to lower quality of life (2, 3).
To combat this challenge, several emerging assistive technologies that improve quality of life in older populations have been explored, including Internet-based physical activity programs, gamification to improve physical activity [4], etc. Virtual reality (VR) is also an emerging technology with the potential to improve well-being and quality of life [5], muscle activity and balance, and physical activity [6], with evidence of beneficial effects on social, emotional states, and cognition [7].
VR offers a highly personalized virtual environment that allows exercises to be tailored to the specific needs of each patient. Users can practice movements in realistic and motivating scenarios, which increases their engagement and motivation during rehabilitation sessions. By allowing complex, customized movements to be simulated, VR facilitates the visualization and repeated practice of actions that, in the physical world, would be difficult or impossible to execute. This constant repetition stimulates the neural pathways associated with movements, promoting neuroplasticity and improving coordination and muscle strength.
Therefore, the purpose of this study is to describe the impact of the application of Immersive Virtual Reality on the mobility and anxiety levels of the participants, as well as to explain adherence, the presence of adverse effects and the usability of this tool.
Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will receive immersive virtual reality sessions twice a week, for a total of 6 weeks, with sessions lasting no more than 30 minutes.
Device: Immersive Virtual Reality with Head Mounted Display
The control group will continue with their usual physiotherapy treatment, which includes aerobic exercises and strength training.
Other: Aerobic exercise and strength training
The intervention will be carried out with an immersive virtual reality device, specifically, with a head mounted display. Specifically, it is the "MetaQuest 3" model.
The combination of aerobic and strength training is part of the conventional physiotherapy treatment carried out at the center.
Anxiety levels
Anxiety levels will be measured using the Generalized Anxiety Disorder (GAD-7).
Time frame: At baseline, at 6 weeks and at 2 months.
Adherence levels
The level of adherence to the intervention will be measured by keeping a record of users who do or do not complete the sessions, in order to establish the dropout rate.
Time frame: At baseline, at 6 weeks and at 2 months
Functional mobility
Functional mobility will include the evaluation of gait and balance using the Tinetti scale (0-28 points).
Time frame: At baseline, at 6 weeks and at 2 months
Ability to perform activities of daily living
The ability to perform activities of daily living will be measured using the Barthel Index (0-100 points).
Time frame: At baseline, at 6 weeks and at 2 months
Cognitive impairment
Cognitive impairment will be measured using the Lobo Mini Cognitive Test.
Time frame: At baseline, at 6 weeks and at 2 months
Usability/Acceptability
The usability or acceptability of the intervention will be measured with the Usability Scales System (SUS).
Time frame: At 6 weeks and at 2 months
Feasibility/cybersickness
The feasibility of the intervention will be measured according to the occurrence of adverse symptomatology associated with the use of virtual reality. For this purpose, the "Simulator Sickness Questionnaire" (SSQ) will be used.
Time frame: At 6 weeks and at 2 months.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Oct 2025, 4 months after the start.
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Universidad de Almeria