A Device for Screening of Fall Risk in the Elderly

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postural Imbalance, Gait, Unsteady

Intervention / Treatment
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* Device: OAK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate/High Risk<br>Participants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment | Device: OAK<br>* The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.<br>|
| Experimental: Low Risk<br>Participants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment | Device: OAK<br>* The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAK failures in the fall risk assessment | Proportion of participants for which the OAK device is not able to provide a fall risk assessment | Baseline | 
| OAK sensitivity in the fall risk assessment | 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events occurring during the assessment | Baseline | 
| Serious adverse events | Serious adverse events occurring during the assessment | Baseline | 
| Rate of falls | Number of falls during the prevoius 6 months | During the previous 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accidental Falls, Risk Assessment, Frail Elderly