ClinicalTrials.Veeva

Menu

A Device for Screening of Fall Risk in the Elderly

I

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status and phase

Completed
Phase 2

Conditions

Gait, Unsteady
Postural Imbalance

Treatments

Device: OAK

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the Centers for Disease Control and Prevention (CDC).

The OAK device is a technologic system, based on virtual reality. It allows to quickly perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact with the OAK device through simple exercises, then the device provides an assessment of their functional mobility, equilibrium and postural reactions.

Full description

Falls are a serious problem among the elderly. Most falls do not cause death, but 20%-30% of falls result in serious injuries representing a significant source of morbidity and mortality. Good evidence shows that many falls can be prevented. Thus, identifying people with risk of falling is crucial. The aim of this study is the evaluation of the screening accuracy of a device (OAK) in assessing fall risk in the elderly.

Participants are recruited at IRCCS Galeazzi Orthopedic Hospital in Milan, among outpatients and healthy volunteers. A brief questionnaire is administered in order to collect data relevant to the CDC Algorithm for Fall Risk Assessment. Then, participants are assessed through the OAK device. The OAK assessment is evaluated in terms of performance, accuracy (in comparison to the CDC Algorithm for Fall Risk Assessment) and safety.

Enrollment

184 patients

Sex

All

Ages

65 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Able to walk without walking aids.
  • Signed informed consent.

Exclusion criteria

  • Neurological, musculoskeletal and orthopaedic disorders limiting mobility function and equilibrium. Psychiatric disorders. Any other medical condition limiting mobility function, as diabetes, obesity, serious ocular disorders (e.g. glaucoma), vestibular disorders (e.g. labyrinthitis) and proprioceptive disorders (e.g. ataxia).
  • Pacemaker.
  • Surgical interventions for orthopaedic disorders (e.g. knee or hip prosthesis) during the previous 6 months.
  • Drug intake altering coordination and equilibrium (e.g. anti-epileptic, sedative-hypnotic drugs).
  • Pregnancy.

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

184 participants in 2 patient groups

Moderate/High Risk
Experimental group
Description:
Participants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment
Treatment:
Device: OAK
Low Risk
Experimental group
Description:
Participants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment
Treatment:
Device: OAK

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems