{"type":"trials","record":{"id":35259,"source_id":"clinicaltrials-gov","external_id":"NCT07060677","title":"Effectiveness of Immersive Virtual Reality Combined With Occupational Therapy in Reducing Fall Risk and Frailty Among Older Adults","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…","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Universidad Rey Juan Carlos","enrollment":30,"countries":["Spain"],"start_date":"2025-09-15","completion_date":"2025-11-01","last_update_date":"2025-07-16","source_url":"https://clinicaltrials.gov/study/NCT07060677","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"VIRTO-FRAIL","age_range":"65 Years","comparator":"Control Group (CG)","organization":"Universidad Rey Juan Carlos","interventions":["Inmersive Virtual Reality","Conventional occupational therapy sessions"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Functional Independence Measure (FIM) — Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)","Functional Reach Test — Pre-intervention, post-intervention (up to 1 week) and follow-up (3 month)","Timed 'Up and Go' (TUG) — Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)","Clinical Frailty Scale (CFS) — Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)","Kinesix Virtual Reality Therapeutics© Functional Assessment Scale — Pre-intervention, post-intervention (up to 1 week)…","World Health Organization Quality of Life - BREF (WHOQOL-BREF) — Pre-intervention, post-intervention (up to 1 week) and…","Client Satisfaction Questionnaire (CSQ-8) — Post-intervention (up to 1 week)","System Usability Scale (SUS) — Post-intervention (up to 1 week)"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Frailty Syndrome","Older Adults, Balance","Fall Prevention in Healthy Aging","Inmersive Virtual Reality","Conventional occupational therapy sessions"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07060677","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-09-15 to 2025-11-01","comparator":"Control Group (CG)","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.499Z","intervention":["Inmersive Virtual Reality","Conventional occupational therapy sessions"],"participants":30,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Functional Independence Measure (FIM) — Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)","Functional Reach Test — Pre-intervention, post-intervention (up to 1 week) and follow-up (3 month)","Timed 'Up and Go' (TUG) — Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)","Clinical Frailty Scale (CFS) — Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)","Kinesix Virtual Reality Therapeutics© Functional Assessment Scale — Pre-intervention, post-intervention (up to 1 week)…","World Health Organization Quality of Life - BREF (WHOQOL-BREF) — Pre-intervention, post-intervention (up to 1 week) and…","Client Satisfaction Questionnaire (CSQ-8) — Post-intervention (up to 1 week)","System Usability Scale (SUS) — Post-intervention (up to 1 week)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35259","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}