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OpenTrials
Completed

NCT Number: NCT07582900

The Impact of Hunova® Robotic Platform Rehabilitation

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.

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Key information

Conditions

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Aged under 20 and over 95 years.

Treatment and study plan

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

Primary outcomes

  1. Silver Index (SI)

    Time frame: Change in SI between baseline to 6 months

    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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

The Impact of Rehabilitation Using the Hunova® Robotic Platform in an Outpatient Setting: a Retrospective Study

Acronym: HUnFalls

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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