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

Istituto Nazionale di Ricovero e Cura per Anziani43 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Elderly Subjects Risk of Fall

Interventions

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.

Eligibility

Sex: ALLMin age: 65 Months

Medical Language ↔ Plain English

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

Locations (1)

IRCCS INRCA Hospital

Ancona, Italy

Outcomes

Primary Outcomes

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'.

Time frame: baseline and 12 weeks later

Secondary Outcomes

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.

Time frame: 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

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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