A Device for Screening of Fall Risk in the Elderly

Phase 2

Completed

• Conditions: Gait, Unsteady; Postural Imbalance

• Registration Number: NCT02655796
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-14
• Primary Completion: 2016-12
• Status Verified: 2017-02
• Study Completion: 2017-05
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
OAK failures in the fall risk assessment	Baseline	Proportion of participants for which the OAK device is not able to provide a fall risk assessment
OAK sensitivity in the fall risk assessment	Baseline	Proportion 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 Outcome Measures

Name	Time	Method
Adverse events	Baseline	Adverse events occurring during the assessment
Serious adverse events	Baseline	Serious adverse events occurring during the assessment
Rate of falls	During the previous 6 months	Number of falls during the prevoius 6 months

Trial Locations

Locations (1)

IRCCS Galeazzi Orthopedic Hospital; 🇮🇹 Milan, Italy