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A Device for Screening of Fall Risk in the Elderly

Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02655796
Enrollment
184
Registered
2016-01-14
Start date
2015-11-30
Completion date
2017-05-31
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Unsteady, Postural Imbalance

Keywords

Accidental Falls, Risk Assessment, Frail Elderly

Brief summary

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.

Detailed 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.

Interventions

DEVICEOAK

The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
OAK failures in the fall risk assessmentBaselineProportion of participants for which the OAK device is not able to provide a fall risk assessment
OAK sensitivity in the fall risk assessmentBaselineProportion of participants assessed by the OAK device as moderate/high risk of falling among those at moderate/high risk according to the CDC Algorithm for Fall Risk Assessment

Secondary

MeasureTime frameDescription
Adverse eventsBaselineAdverse events occurring during the assessment
Serious adverse eventsBaselineSerious adverse events occurring during the assessment
Rate of fallsDuring the previous 6 monthsNumber of falls during the prevoius 6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026