Patient FallNOCADINRIABNCT05879315
Evaluation of Balance and Movement in Order to Prevent the Risk of Falling in the Post-operative Period
A study testing Fall risk prevention in hospital in people with Patient Fall, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This study aims to identify, in patients undergoing hip and knee joint replacement, the functional evaluation tools predictive of the risk of falling upon admission to the orthopedic department and to correlate the results obtained with clinical evaluation scales that are generally used for fall risk stratification… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Fall
- What is being tested?
- Fall risk prevention in hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient's ability to perform the required tests, the understanding of the language of the study
- Patients of both sexes between the ages of 50 and 85;
- Patients candidates for hip and knee joint replacement in the Orthopedic Department of the DRS.
Who cannot join
- Non-ambulatory patients, patients with amputation of one of the 2 lower limbs,
- Serious neurological and/or psychiatric diseases
- Patients with vestibular deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stratification of Fall Risk in a Rehabilitation Department Through Tools That Evaluate Postural Balance and Movement Capacity in the Preoperative Period
This study aims to identify, in patients undergoing hip and knee joint replacement, the functional evaluation tools predictive of the risk of falling upon admission to the orthopedic department and to correlate the results obtained with clinical evaluation scales that are generally used for fall risk stratification and the number of falls actually occurring both in the orthopedic department and in the rehabilitation department.
Read the detailed description
The goal of this prospective interventional cohort study is to identify functional assessment tools predictive of the risk of falling in patients undergoing hip and knee joint replacement surgery upon admission to an orthopedic department and to correlate the results obtained with the clinical rating scales generally used for the risk stratification of fall. All patients upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, all patients will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale), The scores obtained from the various measures used in the patients will be correlated to any falls recorded during hospitalization with the aim to obtain a stratification of falls risk in those patients.
- Conditions
- Patient Fall
- Being tested
- Fall risk prevention in hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall risk prevention in hospitalOther
All patients (hip and knee) upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, hip and knee will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale)
| Study group | Role | What they receive |
|---|---|---|
| risk stratification of fall in patients waiting for hip and knee surgery | Other | Not described Receives: Other: Fall risk prevention in hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test UP and GO. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.
Participants have been instructed to get up from a chair, walk up to a sign marked on the floor 3 meter ahead on the chair, turn around in their own circles, walk up to the chair and sit down. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.
Measured: Just Baseline
Four Square Step Test. The time of performance is measured in seconds
This test evaluates the dynamic balance of patients. The test involves the execution of a pre-established series of steps (forward, lateral, backward) within four squares. The time taken to complete one clockwise and one counterclockwise revolution is taken as a reference parameter.
The 15-second threshold helps us assess the risk of falling in the population being studied.
Times longer than 15 seconds are associated with a higher risk of falling. The young population is around 6-7 seconds.
Measured: Just Baseline
Barthel Index. It is a questionnaire
The index, has it to establish the patient's degree of independence. It is made up of 10 items that include the municipalities daily activities (ADL Activities of Daily Living). Each item is assigned a score, the sum (maximum 100) indicates the degree of autonomy of the patient in carrying out the activities of daily life, the higher the score, the greater the autonomy of the subject.
Measured: Just Baseline
Cumulative Illness Rating Scale. The scale has a cumulative score, which can range from 0 to 56
It is a standardized tool used in the medical field to measure the patient's health as objectively as possible. The tool is clinical in nature and requires the physician to evaluate and measure the clinical and functional severity of 14 categories of disease. For each of these pathologies a severity value must be defined, based on the clinical history, the physical examination and the symptoms declared by the patient. The scale has a cumulative score, which can range from 0 to 56. According to its developers, the maximum score is not compatible with the patient's life.
Measured: Just Baseline
Stabilometric Test
The posturographic analysis has been led by stabilometric platform. The partecipations underwent a static analysis (stabilometric examina-tion) maintaining standing position with feet placed together with an angle of 30 grades between right and left heels at 2 cm of distance, firstly with open eyes for 51.2 seconds and after that with closed eyes for 51.2 seconds too, in order to analyse the time and frequency of oscillations and self-adjustments of the patient excluding the visual input.
Measured: Just Baseline
Morse Scale. It is a questionnaire.
The Morse scale is a quick and easy way to assess a patient's likelihood of falling. The questions in the questionnaire should be addressed to the patient or, if there are physical and cognitive problems that prevent him from responding to a family member. It is a scale composed of 6 items: (i) history of falls, (ii) presence of pathologies at risk, (iii) outpatient aids, (iv) intravenous therapy, (v) type of gait and (vi) mental state". Each answer has a score.
The sum of the scores obtained defines the risk of falling:
0 to 24 = low risk 25 to 50 = medium risk equal to or > 51 = high risk
Measured: Just Baseline
International classification of functioning, disability and health
The general function of the ICF classification is to provide a standard and unified language that serves as a reference model for the description of health and related states. It defines the components of health and some related components such as education and Work.
The domains (= a practical and meaningful set of physiological functions, anatomical structures, actions, tasks, or related life areas) contained in the ICF can, therefore, be seen as domains of the health and related domains. These domains are described from a bodily, individual and social point of view in two lists main:
- Body functions and structures
- Activities and Participation
The ICF is therefore no longer a classification of diseases (1980 version) but has instead become one classification of components of health.
Measured: Just Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start20 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient FallStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- serena rizzo, Principal investigator, Rizzoli Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879315
- Sponsor's protocol ID
- CE AVEC: 888/2022/Sper/IOR
- Acronym
- NOCADINRIAB
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2023
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification of Fall Risk in a Rehabilitation Department Through Tools That Evaluate Postural Balance and Movement Capacity in the Preoperative Period
- ClinicalTrials.gov ID
- NCT05879315
- Acronym / sponsor ID
- NOCADINRIAB / CE AVEC: 888/2022/Sper/IOR
- Conditions
- Patient Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 May 2023 (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.
This study aims to identify, in patients undergoing hip and knee joint replacement, the functional evaluation tools predictive of the risk of falling upon admission to the orthopedic department and to correlate the results obtained with clinical evaluation scales that are generally used for fall risk stratification and the number of falls actually occurring both in the orthopedic department and in the rehabilitation department.
Detailed description
The goal of this prospective interventional cohort study is to identify functional assessment tools predictive of the risk of falling in patients undergoing hip and knee joint replacement surgery upon admission to an orthopedic department and to correlate the results obtained with the clinical rating scales generally used for the risk stratification of fall. All patients upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, all patients will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale), The scores obtained from the various measures used in the patients will be correlated to any falls recorded during hospitalization with the aim to obtain a stratification of falls risk in those patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| risk stratification of fall in patients waiting for hip and knee surgery | Other | Other: Fall risk prevention in hospital |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient's ability to perform the required tests, the understanding of the language of the study
- Patients of both sexes between the ages of 50 and 85;
- Patients candidates for hip and knee joint replacement in the Orthopedic Department of the DRS.
Key exclusion criteria (3 listed)
- Non-ambulatory patients, patients with amputation of one of the 2 lower limbs,
- Serious neurological and/or psychiatric diseases
- Patients with vestibular deficits
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 |
|---|---|---|
| Fall risk prevention in hospitalAll patients (hip and knee) upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, hip and knee will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale) | Other | risk stratification of fall in patients waiting for hip and knee surgery |
Primary outcome
Test UP and GO. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.
Time frame: Just Baseline
Participants have been instructed to get up from a chair, walk up to a sign marked on the floor 3 meter ahead on the chair, turn around in their own circles, walk up to the chair and sit down. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.
Four Square Step Test. The time of performance is measured in seconds
Time frame: Just Baseline
This test evaluates the dynamic balance of patients. The test involves the execution of a pre-established series of steps (forward, lateral, backward) within four squares. The time taken to complete one clockwise and one counterclockwise revolution is taken as a reference parameter. The 15-second threshold helps us assess the risk of falling in the population being studied. Times longer than 15 seconds are associated with a higher risk of falling. The young population is around 6-7 seconds.
Barthel Index. It is a questionnaire
Time frame: Just Baseline
The index, has it to establish the patient's degree of independence. It is made up of 10 items that include the municipalities daily activities (ADL Activities of Daily Living). Each item is assigned a score, the sum (maximum 100) indicates the degree of autonomy of the patient in carrying out the activities of daily life, the higher the score, the greater the autonomy of the subject.
Cumulative Illness Rating Scale. The scale has a cumulative score, which can range from 0 to 56
Time frame: Just Baseline
It is a standardized tool used in the medical field to measure the patient's health as objectively as possible. The tool is clinical in nature and requires the physician to evaluate and measure the clinical and functional severity of 14 categories of disease. For each of these pathologies a severity value must be defined, based on the clinical history, the physical examination and the symptoms declared by the patient. The scale has a cumulative score, which can range from 0 to 56. According to its developers, the maximum score is not compatible with the patient's life.
Stabilometric Test
Time frame: Just Baseline
The posturographic analysis has been led by stabilometric platform. The partecipations underwent a static analysis (stabilometric examina-tion) maintaining standing position with feet placed together with an angle of 30 grades between right and left heels at 2 cm of distance, firstly with open eyes for 51.2 seconds and after that with closed eyes for 51.2 seconds too, in order to analyse the time and frequency of oscillations and self-adjustments of the patient excluding the visual input.
Morse Scale. It is a questionnaire.
Time frame: Just Baseline
The Morse scale is a quick and easy way to assess a patient's likelihood of falling. The questions in the questionnaire should be addressed to the patient or, if there are physical and cognitive problems that prevent him from responding to a family member. It is a scale composed of 6 items: (i) history of falls, (ii) presence of pathologies at risk, (iii) outpatient aids, (iv) intravenous therapy, (v) type of gait and (vi) mental state". Each answer has a score. The sum of the scores obtained defines the risk of falling: 0 to 24 = low risk 25 to 50 = medium risk equal to or > 51 = high risk
International classification of functioning, disability and health
Time frame: Just Baseline
The general function of the ICF classification is to provide a standard and unified language that serves as a reference model for the description of health and related states. It defines the components of health and some related components such as education and Work. The domains (= a practical and meaningful set of physiological functions, anatomical structures, actions, tasks, or related life areas) contained in the ICF can, therefore, be seen as domains of the health and related domains. These domains are described from a bodily, individual and social point of view in two lists main: 1. Body functions and structures 2. Activities and Participation The ICF is therefore no longer a classification of diseases (1980 version) but has instead become one classification of components of health.
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 23 Feb 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.
serena rizzo principal investigator
Rizzoli Orthopedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall risk prevention in hospital in people with Patient Fall, run by Istituto Ortopedico Rizzoli 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 3 inclusion and 3 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 23 Feb 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?
Test UP and GO. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk. (time frame: Just Baseline). The study lists 7 primary outcomes in all. 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 23 Feb 2026.