Clinical trial NCT05846776: Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy
Official title: Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly Subjects
Risk of Fall
Keywords: ageing
rehabilitation
technological system
artificial intelligence
risk of fall
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2023-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Usability
timeFrame: baseline and 12 weeks later
Secondary outcomes:
measure: Cognitive impairment
timeFrame: baseline and 12 weeks later
measure: Falling risk
timeFrame: baseline and 12 weeks later
measure: Health Questionnaire (EQ-5D-5L)
timeFrame: baseline and 12 weeks later
measure: Time Up and Go test (TUG)
timeFrame: baseline and 12 weeks later
measure: Physical performance
timeFrame: baseline and 12 weeks later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Cristina Gagliardi
role: STUDY_CHAIR
References: