A Device for Screening of Fall Risk in the Elderly

Gait, Unsteady Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655796
• Other study ID #: OAK
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2016
• Last updated: June 28, 2017
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady
• Postural Imbalance

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Galeazzi Orthopedic Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse events	Adverse events occurring during the assessment	Baseline
Secondary	Serious adverse events	Serious adverse events occurring during the assessment	Baseline
Secondary	Rate of falls	Number of falls during the prevoius 6 months	During the previous 6 months