CClinicalTrials.gg
CompletedNCT07582900HUnFallsUpdated May 13, 2026

The Impact of Hunova® Robotic Platform Rehabilitation

An observational study in Adult, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 20 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
355
Ages
20 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adult
03

In context

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Aged under 20 and over 95 years.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
355 participants (actual)
Patient registry
No

Interventions

  • Otherdata collection

    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

06

What researchers measure

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

    Time frame: Change in SI between baseline to 6 months

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Rome, Italy 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07582900
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
GIOVANNINI SILVIA (Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
May 13, 2026
Start date
May 6, 2026
Primary completion
May 6, 2026
Completion
May 6, 2026
Last update
May 13, 2026

Study contacts

Silvia Giovannini, MD, PhD
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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