The Impact of Hunova® Robotic Platform Rehabilitation

NCT07582900 | Completed

• 1 other identifier: 27230
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

A fall is defined as "a sudden, unintentional, and unexpected downward movement from a standing, sitting, or lying position". According to the World Health Organization (WHO) in 2021, falls are the second leading cause of death from unintentional injuries globally, after deaths caused by road traffic accidents, with approximately 684,000 deaths per year. Of these falls, about 80% occur in low- and middle-income settings. In addition to fatal outcomes, the WHO estimates that approximately 37 million people exposed to falls require medical care annually and that falls are responsible for increased disability and healthcare costs, as well as a reduction in remaining independence. Various risk factors, both intrinsic and extrinsic, have been identified that significantly increase an individual's risk of falling. Intrinsic risk factors include age and gender, health status, mobility and sensory impairments, and cognitive abilities. Extrinsic risk factors include environmental hazards, footwear, and assistive devices. Falls represent one of the major public health issues among the elderly population: approximately 40% of adults over the age of 65 living at home experience at least one fall per year, and of these, one in forty is hospitalized or requires medical care. Among geriatric patients admitted to assisted living facilities, the average fall rate exceeds 2.5 falls per person-year for the same age group, which is three times higher than that recorded among older adults living at home. Falls occurring in hospital or residential settings are associated with a higher risk of serious injury to the patient, prolonged recovery and hospitalization, as well as a higher risk of subsequent rehospitalization compared to those experienced by individuals living at home: fall-related injuries are the third leading cause of rehospitalization within 30 days for individuals over 65, accounting for an average of 5.1% of all readmissions; this percentage rises to 10% for patients already hospitalized due to a previous fall. Since falls are therefore not only an extremely common occurrence but also a critical indicator of vulnerability in geriatric patients discharged from the hospital, it is necessary to improve fall prevention and risk monitoring programs both in general and during the post-acute period, when older adults are particularly vulnerable. The hospital setting, therefore, exacerbates the vulnerability of older adults; guidelines recommend adopting, in such settings, a multifactorial and continuous approach that includes staff training, ongoing risk assessment for each individual patient, and the removal of environmental barriers. More recently, some authors have highlighted the need to conduct a specialized multidisciplinary and multifactorial assessment even for patients at low risk of falling or who have fallen outside a hospital or residential setting, aimed at reducing modifiable, intrinsic, and extrinsic risk factors, as well as implementing balance-enhancement programs. Since 2022, the A. Gemelli University Polyclinic Foundation IRCCS has been operating the Clinical Care Pathway (CCP) for fall prevention and active aging, dedicated to patients who wish to maintain or improve their independence in activities of daily living and social participation by addressing various aspects of balance. With this in mind, the aim of the study is to retrospectively collect data from patients who accessed the CCP for fall prevention and active aging, analyzing its effects over time.

Conditions

Adult

Outcome Measures

Primary Outcomes (1)

• Silver Index (SI)

  Fall risk assessment, evaluated during clinical practice using the Hunova robotic platform. The Silver Index is a score ranging from 0 to 100. Higher scores indicate a greater risk of falling

  Change in SI between baseline to 6 months

Interventions

data collection OTHER

Collection of demographic and anthropometric data, as well as clinical characteristics: age, gender, education level, body mass index, date of examination, past medical history, current medical condition, current medication, date of the first visit, number of falls in the past 6 months, and fall risk score using the Silver Index

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients

You may qualify if:

• Aged between 20 and 95 years;
• Have undergone at least one fall risk assessment using the hunova® robotic platform

You may not qualify if:

• Aged under 20 and over 95 years.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168, Italy

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Silvia Giovannini, MD, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start: May 6, 2026
• Primary Completion: May 6, 2026
• Study Completion: May 6, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)