People With DependencyREVIVIRNCT06928155
Inclusive Rehabilitation: Virtual Reality as a Tool to Improve the Quality of Life of Dependent Persons
A study testing Immersive Virtual Reality with Head Mounted Display and Aerobic exercise and strength training in people with People With Dependency, run by Universidad de Almeria at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- People With Dependency
- What is being tested?
- Immersive Virtual Reality with Head Mounted Display and Aerobic exercise and strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2025to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Patients who agree to participate in the study and sign the informed consent form.
Who cannot join
- Those with severe visual impairment, vertigo, epilepsy or psychosis, and who may interfere with the normal performance of interactive voice response (IVR) tasks, will be excluded as a precaution.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Asociación "El Saliente"
Almería, Andalusia, 04007
About this study
Official title: Feasibility and Usability of Immersive Virtual Reality for People With Dependency
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.
Read the detailed description
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.
- Conditions
- People With Dependency
- Being tested
- Immersive Virtual Reality with Head Mounted Display, Aerobic exercise and strength training
- Keywords
- quality of life, dependency, virtual reality, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality with Head Mounted DisplayDevice
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.
Aerobic exercise and strength trainingOther
The combination of aerobic and strength training is part of the conventional physiotherapy treatment carried out at the center.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Immersive Virtual Reality with Head Mounted Display |
| Control group | Active comparator | The control group will continue with their usual physiotherapy treatment, which includes aerobic exercises and strength training. Receives: Other: Aerobic exercise and strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels
Anxiety levels will be measured using the Generalized Anxiety Disorder (GAD-7).
Measured: At baseline, at 6 weeks and at 2 months.
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: At baseline, at 6 weeks and at 2 months
Cognitive impairment
Cognitive impairment will be measured using the Lobo Mini Cognitive Test.
Measured: 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).
Measured: 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.
Measured: At 6 weeks and at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Jun 2025
- Primary completion28 Oct 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With DependencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Romero-del Rey, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928155
- Sponsor's protocol ID
- TRFE-SI-2024/005
- Acronym
- REVIVIR
- Status last verified
- Jul 2025
- First submitted
- 7 Apr 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usability of Immersive Virtual Reality for People With Dependency
- ClinicalTrials.gov ID
- NCT06928155
- Acronym / sponsor ID
- REVIVIR / TRFE-SI-2024/005
- Conditions
- People With Dependency
- Keywords
- quality of life, dependency, virtual reality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 28 Oct 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Immersive Virtual Reality with Head Mounted DisplayThe 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. |
| Control group | Active comparator | Other: Aerobic exercise and strength trainingThe control group will continue with their usual physiotherapy treatment, which includes aerobic exercises and strength training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age
- Patients who agree to participate in the study and sign the informed consent form.
Key exclusion criteria (1 listed)
- Those with severe visual impairment, vertigo, epilepsy or psychosis, and who may interfere with the normal performance of interactive voice response (IVR) tasks, will be excluded as a precaution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality with Head Mounted DisplayThe intervention will be carried out with an immersive virtual reality device, specifically, with a head mounted display. Specifically, it is the "MetaQuest 3" model. | Device | Intervention group |
| Aerobic exercise and strength trainingThe combination of aerobic and strength training is part of the conventional physiotherapy treatment carried out at the center. | Other | Control group |
Primary outcome
Anxiety levels
Time frame: At baseline, at 6 weeks and at 2 months.
Anxiety levels will be measured using the Generalized Anxiety Disorder (GAD-7).
6 secondary outcomes
Adherence levels
Time frame: At baseline, at 6 weeks and at 2 months
Functional mobility
Time frame: At baseline, at 6 weeks and at 2 months
Ability to perform activities of daily living
Time frame: At baseline, at 6 weeks and at 2 months
Cognitive impairment
Time frame: At baseline, at 6 weeks and at 2 months
Usability/Acceptability
Time frame: At 6 weeks and at 2 months
Feasibility/cybersickness
Time frame: At 6 weeks and at 2 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality with Head Mounted Display and Aerobic exercise and strength training in people with People With Dependency, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raúl Romero del Rey, Doctor of Physiotherapy (+34645127620, rrd239@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels (time frame: At baseline, at 6 weeks and at 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.