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

NCT06928155 | Recruiting

• 1 other identifier: TRFE-SI-2024/005
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

People With Dependency

Keywords

quality of life, dependency, virtual reality, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Anxiety levels

  Anxiety levels will be measured using the Generalized Anxiety Disorder (GAD-7).

  At baseline, at 6 weeks and at 2 months.

Secondary Outcomes (6)

• Adherence levels

  At baseline, at 6 weeks and at 2 months

• Functional mobility

  At baseline, at 6 weeks and at 2 months

• Ability to perform activities of daily living

  At baseline, at 6 weeks and at 2 months

• Cognitive impairment

  At baseline, at 6 weeks and at 2 months

• Usability/Acceptability

  At 6 weeks and at 2 months

Study Arms (2)

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.

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.

Other: Aerobic exercise and strength training

Interventions

Immersive Virtual Reality with Head Mounted Display DEVICE

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.

Intervention group

Aerobic exercise and strength training OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Asociación "El Saliente"

Almería, Andalusia, 04007, Spain

RECRUITING

MeSH Terms

Interventions

Smart Glasses; Exercise; Resistance Training

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Central Study Contacts

Raúl Romero del Rey, Doctor of Physiotherapy

CONTACT

+34645127620; rrd239@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: June 1, 2025
• Primary Completion: October 28, 2025
• Study Completion: December 28, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)