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Completed

NCT Number: NCT05846776

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

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.

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Key information

Conditions

Elderly Subjects Risk of Fall

Age range

65 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS INRCA Hospital

Ancona, 60127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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'.

Secondary outcomes

  1. Cognitive impairment

    Time frame: baseline and 12 weeks later

    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.

  2. Falling risk

    Time frame: baseline and 12 weeks later

    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

  3. Health Questionnaire (EQ-5D-5L)

    Time frame: baseline and 12 weeks later

    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)

  4. Time Up and Go test (TUG)

    Time frame: baseline and 12 weeks later

    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.

  5. Physical performance

    Time frame: baseline and 12 weeks later

    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

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Collaborators

  • European Union

Registry information

Acronym: PRECISE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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