Clinical Trial: A Device for Screening of Fall Risk in the Elderly
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design
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 Summary:
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.
Sponsor: Istituto Ortopedico Galeazzi
Current Primary Outcome:
- OAK failures in the fall risk assessment [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse events [ Time Frame: Baseline ]Adverse events occurring during the assessment
- Serious adverse events [ Time Frame: Baseline ]Serious adverse events occurring during the assessment
- Rate of falls [ Time Frame: During the previous 6 months ]Number of falls during the prevoius 6 months
Original Secondary Outcome: Same as current
Information By: Istituto Ortopedico Galeazzi
Dates:
Date Received: January 12, 2016
Date Started: November 2015
Date Completion: May 2017
Last Updated: February 13, 2017
Last Verified: February 2017
