Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy

NCT ID: NCT05846776

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2024-02-02

Brief 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 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.

Conditions

Elderly Subjects; Risk of Fall

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

elderly subjects at risk of fall

Group Type: EXPERIMENTAL

DigiPrehab system

Intervention Type: DEVICE

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.

Interventions

DigiPrehab system

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristina Gagliardi

Role: STUDY_CHAIR

IRCCS INRCA, Ancona, Italy

Locations

IRCCS INRCA Hospital

Ancona, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 38584921 (View on PubMed)

Other Identifiers

INRCA_006_2023

Identifier Type: -

Identifier Source: org_study_id