AdultHUnFallsNCT07582900
The Impact of Hunova® Robotic Platform Rehabilitation
An observational study of Adult, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Adult
- What is being tested?
- data collection
- How many people
- 355 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2026to 6 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients
Who may be able to join
- Aged between 20 and 95 years;
- Have undergone at least one fall risk assessment using the hunova® robotic platform
Who cannot join
- Aged under 20 and over 95 years.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
About this study
Official title: The Impact of Rehabilitation Using the Hunova® Robotic Platform in an Outpatient Setting: a Retrospective Study
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.
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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
- Being tested
- data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in SI between baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start6 May 2026
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIOVANNINI SILVIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Silvia Giovannini, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582900
- Sponsor's protocol ID
- 27230
- Acronym
- HUnFalls
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Rehabilitation Using the Hunova® Robotic Platform in an Outpatient Setting: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07582900
- Acronym / sponsor ID
- HUnFalls / 27230
- Conditions
- Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients
Key inclusion criteria (2 listed)
- Aged between 20 and 95 years;
- Have undergone at least one fall risk assessment using the hunova® robotic platform
Key exclusion criteria (1 listed)
- Aged under 20 and over 95 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionCollection 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 | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Giovannini, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silver Index (SI) (time frame: Change in SI between baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.