ClinicalTrials.gg
RecruitingNCT06928155REVIVIRUpdated Jul 29, 2025

Inclusive Rehabilitation: Virtual Reality as a Tool to Improve the Quality of Life of Dependent Persons

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

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • People With Dependency

Keywords

  • quality of life, dependency, virtual reality, rehabilitation
03

In context

Lead sponsor

Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age
  • Patients who agree to participate in the study and sign the form.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
172 participants (estimated)

Study arms

  • Experimental
    Intervention group

    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

  • Active comparator
    Control group

    The control group will continue with their usual physiotherapy treatment, which includes aerobic exercises and strength training.

    Other: Aerobic exercise and strength training

Interventions

  • DeviceImmersive Virtual Reality with Head Mounted Display

    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.

  • OtherAerobic exercise and strength training

    The combination of aerobic and strength training is part of the conventional physiotherapy treatment carried out at the center.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Cognitive impairment

    Cognitive impairment will be measured using the Lobo Mini Cognitive Test.

    Time frame: At baseline, at 6 weeks and at 2 months

  5. 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

  6. 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.

07

Study locations

1 of 1 sites recruiting
  • Asociación "El Saliente"
    Almería, Andalusia 04007, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Oct 2025, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
Apr 15, 2025
StartActual
Jun 1, 2025
Primary completionEst.
Oct 28, 2025
CompletionEst.
Dec 28, 2025
Last update
Jul 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06928155
Lead sponsor
Universidad de Almeria
Responsible party
Raul Romero-del Rey (Ph.D., Universidad de Almeria) — Principal investigator
First posted
Apr 15, 2025
Start date
Jun 1, 2025
Primary completion
Oct 28, 2025 (estimated)
Completion
Dec 28, 2025 (estimated)
Last update
Jul 29, 2025

Study contacts

Raúl Romero del Rey, Doctor of Physiotherapy
Contact
rrd239@ual.es
+34645127620

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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