A Device for Screening of Fall Risk in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-05-31

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.

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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.

Conditions

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Postural Imbalance Gait, Unsteady

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Moderate/High Risk

Participants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment

Group Type EXPERIMENTAL

OAK

Intervention Type DEVICE

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

Low Risk

Participants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment

Group Type EXPERIMENTAL

OAK

Intervention Type DEVICE

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

Interventions

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OAK

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

Intervention Type DEVICE

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes