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

NCT05846776 | Completed

• 1 other identifier: INRCA_006_2023
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Subjects; Risk of Fall

Keywords

ageing; rehabilitation; technological system; artificial intelligence; risk of fall

Outcome Measures

Primary Outcomes (1)

• 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'.

  baseline and 12 weeks later

Secondary Outcomes (5)

• Cognitive impairment

  baseline and 12 weeks later

• Falling risk

  baseline and 12 weeks later

• Health Questionnaire (EQ-5D-5L)

  baseline and 12 weeks later

• Time Up and Go test (TUG)

  baseline and 12 weeks later

• Physical performance

  baseline and 12 weeks later

Study Arms (1)

elderly subjects at risk of fall

EXPERIMENTAL

Device: DigiPrehab system

Interventions

DigiPrehab system 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.

elderly subjects at risk of fall

Eligibility Criteria

• Age: 65 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• European Union: collaborator

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

Related Publications (1)

• 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.

  PMID: 38584921 DERIVED

Study Officials

• Cristina Gagliardi

  IRCCS INRCA, Ancona, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: October 26, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

IT (1)