Clinical trial NCT02655796: A Device for Screening of Fall Risk in the Elderly
Official title: Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postural Imbalance
Gait, Unsteady
Keywords: Accidental Falls
Risk Assessment
Frail Elderly
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 184
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OAK failures in the fall risk assessment
timeFrame: Baseline
measure: OAK sensitivity in the fall risk assessment
timeFrame: Baseline
Secondary outcomes:
measure: Adverse events
timeFrame: Baseline
measure: Serious adverse events
timeFrame: Baseline
measure: Rate of falls
timeFrame: During the previous 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
affiliation: banfi.giuseppe@fondazionesanraffaele.it
name: Giuseppe Banfi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castellini G, Gianola S, Stucovitz E, Tramacere I, Banfi G, Moja L. Diagnostic test accuracy of an automated device as a screening tool for fall risk assessment in community-residing elderly: A STARD compliant study. Medicine (Baltimore). 2019 Sep;98(39):e17105. doi: 10.1097/MD.0000000000017105.