Population aging is a growing global phenomenon that poses significant challenges to healthcare systems, particularly in preventing falls and managing frailty among older adults. Falls remain a leading cause of morbidity and mortality in this population, affecting approximately one-third of individuals over 65 each year. At the same time, frailty syndrome (FS)-a clinical condition marked by progressive decline in physical and cognitive function-significantly increases the risk of falls, disability, and dependency. Pre-frailty, an intermediate and reversible stage, offers a key opportunity for preventive interventions.
Scientific evidence supports the effectiveness of interdisciplinary approaches to address frailty and fall prevention. In this context, occupational therapy plays a central role by promoting functional autonomy through meaningful activities. However, traditional approaches may be limited in individuals with low motivation or mild cognitive impairment. Therefore, integrating innovative technologies such as immersive virtual reality (IVR) emerges as a promising therapeutic strategy.
IVR enables users to interact with simulated three-dimensional environments, enhancing cognitive stimulation, motor training, and treatment adherence. Modern devices like the Meta Quest 3 headsets provide accessible, safe, and adaptable immersive experiences, with reported benefits in balance, gait, attention, and motivation. Nonetheless, no studies to date have specifically evaluated the effectiveness of this technology when combined with conventional occupational therapy to reduce fall risk and frailty in older adults.
This project proposes a pilot randomized controlled trial (RCT), lasting 5 months, using a single-blind, parallel-group design. It will be conducted at the Bouco Madrid Ferraz Residential Center (Madrid, Spain), following CONSORT 2010 methodological guidelines. The primary aim is to assess the efficacy of a combined intervention using IVR through Meta Quest 3 headsets and occupational therapy, compared to conventional occupational therapy alone, in reducing fall risk, improving frailty status, enhancing quality of life, and increasing rehabilitation motivation in older adults.
The sample will include 30 participants (15 per group), selected based on specific inclusion and exclusion criteria. Participants will be randomly assigned to a control group (CG), receiving standard occupational therapy, or to an experimental group (EG), receiving a combined intervention of occupational therapy and IVR using the Kinesix XR platform, which is designed to enhance balance.
The intervention will last 8 weeks, with two one-hour sessions per week. The experimental group will receive 30 minutes of occupational therapy and 30 minutes of IVR per session. Assessments will be conducted at baseline, post-intervention, and at a 3-month follow-up using validated scales to measure fall risk, balance, frailty level, quality of life, and satisfaction.
Data will be pseudonymized, statistically analyzed using SPSS, and managed in compliance with the European General Data Protection Regulation (EU 2016/679). The small sample size reflects the exploratory nature of the study, aimed at assessing feasibility, safety, and preliminary outcomes prior to conducting a larger-scale trial.
Ultimately, this project aims to provide initial evidence on an innovative intervention for older adults by integrating digital tools with conventional therapeutic approaches. If proven effective, the VIRTO-FRAIL model could lay the groundwork for new strategies in geriatric rehabilitation and fall prevention.
Individuals aged 65 years or older
Regularly attending rehabilitation treatment at the Bouco Madrid Ferraz Residence
Having the ability to walk with or without assistive devices
Presenting sufficient cognitive capacity to understand instructions (score ≥ 24 on the MMSE)
Having a diagnosis of a severe neurological disease (such as advanced Parkinson's disease or ALS, among others)
Having a history of epilepsy or seizures (due to potential adverse effects with VR)
Experiencing cardiovascular instability or having a medical contraindication for physical activity
Presenting vestibular disorders
Parallel
Inmersive Virtual Reality
Procedure/SurgeryParticipants will receive a intervention of immersive virtual reality using Meta Quest 3 and the Kinesix XR platform. Sessions will take place twice per week for 8 weeks. The IVR component will focus on balance and mobility through interactive, immersive environments designed to enhance engagement, adherence, and functional outcomes. This multimodal approach aims to reduce fall risk and frailty while improving motivation and quality of life in older adults.
Conventional occupational therapy sessions
Procedure/SurgeryParticipants will receive conventional occupational therapy only, with sessions conducted twice per week for 8 weeks. The intervention will focus on cognitive stimulation, manipulative skill training, and psychomotor exercises, all adapted to the functional level of each participant. Activities aim to maintain or improve autonomy, balance, and coordination, following established occupational therapy guidelines for older adults. No immersive virtual reality or digital technology will be included in this group. This control condition allows for comparison with the experimental group to evaluate the added value of immersive virtual reality in fall risk and frailty reduction.
Functional Independence Measure (FIM)
An instrument that assesses the level of functional independence in activities of daily living. It provides information primarily on motor and cognitive performance through 18 items. Each item is scored from 1 to 7, with higher scores indicating greater functional independence. The assessment is conducted through task observation and interview.
Functional Reach Test
This test measures the maximum distance an individual can shift their center of gravity towards the limits of their base of support. In a relaxed standing posture, with feet hip-width apart, the participant is asked to flex the shoulder to 90 degrees and keep the hand extended. They must then reach forward as far as possible. The examiner records the furthest distance the center of gravity is displaced. Two practice trials and three recorded trials are conducted, with the average of the three being the final score. The result is recorded in centimeters.
Timed 'Up and Go' (TUG)
This test measures the time it takes a person to rise from a chair, walk 3 meters, turn around, return to the chair, and sit down again. It evaluates balance and gait speed. The score is recorded in seconds.
Clinical Frailty Scale (CFS)
A clinical tool used to assess the level of frailty in older adults. It is based on a 9-point scale, where patients are classified from 1 (very fit) to 9 (terminally ill), reflecting increasing severity of frailty. Higher scores indicate worse outcomes, representing greater vulnerability and dependency. The evaluation incorporates physical and cognitive function, as well as the level of dependency, to estimate a patient's vulnerability to stressors.
Client Satisfaction Questionnaire (CSQ-8)
A self-administered questionnaire consisting of 8 items that assess satisfaction with the care and quality of services received, as well as how well the intervention met the patient's expectations. Responses are scored from 1 to 4, with a maximum score of 32; higher scores indicate greater satisfaction. The Spanish adaptation of the questionnaire has shown adequate psychometric properties and preserves the characteristics of the original version, making it suitable for assessing satisfaction with healthcare services in the Spanish population. The CSQ-8 will be administered to both treatment groups in this study.
System Usability Scale (SUS)
A usability evaluation scale used to assess the effectiveness of virtual reality in healthcare settings. It includes 10 items that cover various aspects of the user's experience with the technology, such as ease of use, efficiency, and overall satisfaction. Responses range from "strongly agree" to "strongly disagree."
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