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

July 28, 2025 updated by: Raul Romero-del Rey, Universidad de Almeria

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raúl Romero del Rey, Doctor of Physiotherapy
  • Phone Number: +34645127620
  • Email: rrd239@ual.es

Study Locations

    • Andalucía
      • Almería, Andalucía, Spain, 04007
        • Recruiting
        • Asociación "El Saliente"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Active Comparator: Control group
The control group will continue with their usual physiotherapy treatment, which includes aerobic exercises and strength training.
The combination of aerobic and strength training is part of the conventional physiotherapy treatment carried out at the center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline, at 6 weeks and at 2 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence levels
Time Frame: At baseline, at 6 weeks and at 2 months
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.
At baseline, at 6 weeks and at 2 months
Functional mobility
Time Frame: At baseline, at 6 weeks and at 2 months
Functional mobility will include the evaluation of gait and balance using the Tinetti scale (0-28 points).
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
The ability to perform activities of daily living will be measured using the Barthel Index (0-100 points).
At baseline, at 6 weeks and at 2 months
Cognitive impairment
Time Frame: At baseline, at 6 weeks and at 2 months
Cognitive impairment will be measured using the Lobo Mini Cognitive Test.
At baseline, at 6 weeks and at 2 months
Usability/Acceptability
Time Frame: At 6 weeks and at 2 months
The usability or acceptability of the intervention will be measured with the Usability Scales System (SUS).
At 6 weeks and at 2 months
Feasibility/cybersickness
Time Frame: At 6 weeks and at 2 months.
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.
At 6 weeks and at 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

October 28, 2025

Study Completion (Estimated)

December 28, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TRFE-SI-2024/005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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