Effectiveness of Immersive Virtual Reality Combined With Occupational Therapy in Reducing Fall Risk and Frailty Among Older Adults

NCT ID: NCT07060677

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

Frailty Syndrome; Older Adults, Balance; Fall Prevention in Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group (EG)

Experimental Group (EG), which received therapy with Inmersive Virtual Reality, plus their conventional occupational therapy sessions.

Group Type: EXPERIMENTAL

Inmersive Virtual Reality

Intervention Type: PROCEDURE

Participants 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

Intervention Type: PROCEDURE

Participants 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.

Control Group (CG)

Control Group (CG), which received their usual sessions of conventional occupational therapy.

Group Type: ACTIVE_COMPARATOR

Conventional occupational therapy sessions

Intervention Type: PROCEDURE

Participants 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.

Interventions

Inmersive Virtual Reality

Participants 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.

Intervention Type: PROCEDURE

Conventional occupational therapy sessions

Participants 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)
• Agreeing to participate voluntarily
• Signing the informed consent form.

Exclusion Criteria

• 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
• Participating in other similar intervention programs during the same period
• Being unable to use virtual reality glasses due to intolerance or dizziness
• Not agreeing to participate voluntarily in the study and/or not signing the informed consent form.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Cristina García-Bravo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Rey Juan Carlos

Alcorcón, Marid, Spain

Residencia Bouco Madrid Ferraz

Madrid, , Spain

Countries

Spain

Central Contacts

Cristina García-Bravo

Role: CONTACT

cristina.bravo@urjc.es

914884877

Facility Contacts

Cristina García-Bravo

Role: primary

cristina.bravo@urjc.es

914884877

Melissa Helen Zegarra-Ramos

Role: primary

terapia.madridferraz@emeis.com

915442248

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

080520254252025

Identifier Type: -

Identifier Source: org_study_id