Elderly SubjectsPRECISENCT05846776
Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy
A study testing DigiPrehab system in people with Elderly Subjects and Risk of Fall, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial summary
The PRECISE study is a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan… Read more about this study
- Who is it for?
- Ages 65 months and older
- Conditions the study is for
- Elderly Subjects, Risk of Fall
- What is being tested?
- DigiPrehab system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2022to 2 Feb 2024
- 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 65 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Independent ambulation
- Fall risk assessed by Tinetti test
- Mini Mental State Examination ≥ 24
- Residents at home
- Familiarity with web applications
- Ability and willingness to sign informed consent
Who cannot join
- Unstable clinical condition by judgment of the physician
- Severe visual and/or hearing impairment
- Severe impairment (Activities of Daily Living) in medical record
- Absence of primary caregiver
Trial locations and contacts
1 site in 1 country.
About this study
The PRECISE study is a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.
Read the detailed description
The PRECISE project takes the positive results achieved with the DigiRehab application (https://digirehab.dk/en) in home rehabilitation and takes a further step in this direction by combining the personalized training delivered through the application with an artificial intelligence-based predictive model (Artificial intelligence - Decision Support Systems platform, AI-DSS platform) for fall risk assessment in the elderly. In particular, 20 senior participants will test the DSS beta prototype. This new system, called DigiPrehab, will enable early identification of the elderly with significant risk factors for falling and propose an individualized physical training plan to attend to the identified critical areas.
The PRECISE study will be a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.
- Conditions
- Elderly Subjects, Risk of Fall
- Being tested
- DigiPrehab system
- Keywords
- ageing, rehabilitation, technological system, artificial intelligence, risk of fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigiPrehab systemDevice
Using an Artificial Intelligence-Machine Learning (AI-ML) DSS platform, which analyzes a large collection of data (screening and local data) from different sources, the DigiPrehab system will allow to predict the risk of falling in the elderly subjects. Once the screening will be completed, to carry out the prevention of falls, the system will assign to the participants a personalised exercise program that the patient will carry out at home for 12 weeks. The exercises will be chosen from the following: squat at door, squat on chair, squat with knee-lift, squat with heel-raise, stand-no support, toe-raise with support, toe-raise, one leg balance, weight-shift with support, weight-shift without support, lunge with support, lunge, step on book, step over book, step onto box or stair, step forward-sideways, step forward-sideways-backwards, knee to elbow, timed up and go.
| Study group | Role | What they receive |
|---|---|---|
| elderly subjects at risk of fall | Experimental | Not described Receives: Device: DigiPrehab system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Usability
This outcome will be measured through the System Usability Scale (SUS). It consists of a 10-item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.
Measured: baseline and 12 weeks later
Secondary outcomes (5)
Cognitive impairment
This outcome will be measured by Mini-Mental State Examination (MMSE). It is a neuropsychological test for the evaluation of disorders of intellectual efficiency and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 26 to 30 is an indication of cognitive normality. The score will be adjusted with the coefficient for age and schooling.
Measured: baseline and 12 weeks later
Falling risk
falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score < 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk
Measured: baseline and 12 weeks later
Health Questionnaire (EQ-5D-5L)
The EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
Measured: baseline and 12 weeks later
Time Up and Go test (TUG)
Time up and go test (TUG) is a successful screening method to evaluate the chance of falling. Walking pace, muscle strength and balance, sit-to-walk transition time, turning, walking and walk-to-sit transition are expressed in TUG. Participants take greater than 12 seconds to complete TUG will be at greater risk of fall.
Measured: baseline and 12 weeks later
Physical performance
Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance
Measured: baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start26 Oct 2022
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly SubjectsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Cristina Gagliardi, Study chair, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846776
- Sponsor's protocol ID
- INRCA_006_2023
- Acronym
- PRECISE
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Ambrosio F, Harbo M, Contiero D, Bonfigli AR, Cicconi D, Heuer N, Roos A, Fischer Pedersen C, Fabbietti P, Gagliardi C. Preact to lower the risk of falling by customized rehabilitation across Europe: the feasibility study protocol of the PRECISE project in Italy. Front Public Health. 2024 Mar 22;12:1293621. doi: 10.3389/fpubh.2024.1293621. eCollection 2024.
PubMed 38584921
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy
- ClinicalTrials.gov ID
- NCT05846776
- Acronym / sponsor ID
- PRECISE / INRCA_006_2023
- Conditions
- Elderly Subjects, Risk of Fall
- Keywords
- ageing, rehabilitation, technological system, artificial intelligence, risk of fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 6 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.
The PRECISE study is a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.
Detailed description
The PRECISE project takes the positive results achieved with the DigiRehab application (https://digirehab.dk/en) in home rehabilitation and takes a further step in this direction by combining the personalized training delivered through the application with an artificial intelligence-based predictive model (Artificial intelligence - Decision Support Systems platform, AI-DSS platform) for fall risk assessment in the elderly. In particular, 20 senior participants will test the DSS beta prototype. This new system, called DigiPrehab, will enable early identification of the elderly with significant risk factors for falling and propose an individualized physical training plan to attend to the identified critical areas.
The PRECISE study will be a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly subjects at risk of fall | Experimental | Device: DigiPrehab system |
Who may qualify
- Ages
- 65 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Independent ambulation
- Fall risk assessed by Tinetti test
- Mini Mental State Examination ≥ 24
- Residents at home
- Familiarity with web applications
Key exclusion criteria (4 listed)
- Unstable clinical condition by judgment of the physician
- Severe visual and/or hearing impairment
- Severe impairment (Activities of Daily Living) in medical record
- Absence of primary caregiver
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 |
|---|---|---|
| DigiPrehab systemUsing an Artificial Intelligence-Machine Learning (AI-ML) DSS platform, which analyzes a large collection of data (screening and local data) from different sources, the DigiPrehab system will allow to predict the risk of falling in the elderly subjects. Once the screening will be completed, to carry out the prevention of falls, the system will assign to the participants a personalised exercise program that the patient will carry out at home for 12 weeks. The exercises will be chosen from the following: squat at door, squat on chair, squat with knee-lift, squat with heel-raise, stand-no support, toe-raise with support, toe-raise, one leg balance, weight-shift with support, weight-shift without support, lunge with support, lunge, step on book, step over book, step onto box or stair, step forward-sideways, step forward-sideways-backwards, knee to elbow, timed up and go. | Device | elderly subjects at risk of fall |
Primary outcome
Change in Usability
Time frame: baseline and 12 weeks later
This outcome will be measured through the System Usability Scale (SUS). It consists of a 10-item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.
5 secondary outcomes
Cognitive impairment
Time frame: baseline and 12 weeks later
Falling risk
Time frame: baseline and 12 weeks later
Health Questionnaire (EQ-5D-5L)
Time frame: baseline and 12 weeks later
Time Up and Go test (TUG)
Time frame: baseline and 12 weeks later
Physical performance
Time frame: baseline and 12 weeks later
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 8 Sep 2025.
- Derived from this study: PubMed 38584921D'Ambrosio F, Harbo M, Contiero D, Bonfigli AR, Cicconi D, Heuer N, Roos A, Fischer Pedersen C, Fabbietti P, Gagliardi C. Preact to lower the risk of falling by customized rehabilitation across Europe: the feasibility study protocol of the PRECISE project in Italy. Front Public Health. 2024 Mar 22;12:1293621. doi: 10.3389/fpubh.2024.1293621. eCollection 2024.
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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.
Cristina Gagliardi study chair
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DigiPrehab system in people with Elderly Subjects and Risk of Fall, run by Istituto Nazionale di Ricovero e Cura per Anziani 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 6 inclusion and 4 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 8 Sep 2025. 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?
Change in Usability (time frame: baseline and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846776, which also lists 1 linked publication.
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 8 Sep 2025.