A Device for Screening of Fall Risk in the Elderly
Primary Purpose
Postural Imbalance, Gait, Unsteady
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
OAK
Sponsored by
About this trial
This is an interventional screening trial for Postural Imbalance focused on measuring Accidental Falls, Risk Assessment, Frail Elderly
Eligibility Criteria
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.
Sites / Locations
- IRCCS Galeazzi Orthopedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Moderate/High Risk
Low Risk
Arm Description
Participants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment
Participants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment
Outcomes
Primary Outcome Measures
OAK failures in the fall risk assessment
Proportion of participants for which the OAK device is not able to provide a fall risk assessment
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
Secondary Outcome Measures
Adverse events
Adverse events occurring during the assessment
Serious adverse events
Serious adverse events occurring during the assessment
Rate of falls
Number of falls during the prevoius 6 months
Full Information
NCT ID
NCT02655796
First Posted
January 12, 2016
Last Updated
June 28, 2017
Sponsor
Istituto Ortopedico Galeazzi
1. Study Identification
Unique Protocol Identification Number
NCT02655796
Brief Title
A Device for Screening of Fall Risk in the Elderly
Official Title
Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Imbalance, Gait, Unsteady
Keywords
Accidental Falls, Risk Assessment, Frail Elderly
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate/High Risk
Arm Type
Experimental
Arm Description
Participants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment
Arm Title
Low Risk
Arm Type
Experimental
Arm Description
Participants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment
Intervention Type
Device
Intervention Name(s)
OAK
Intervention Description
The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.
Primary Outcome Measure Information:
Title
OAK failures in the fall risk assessment
Description
Proportion of participants for which the OAK device is not able to provide a fall risk assessment
Time Frame
Baseline
Title
OAK sensitivity in the fall risk assessment
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events occurring during the assessment
Time Frame
Baseline
Title
Serious adverse events
Description
Serious adverse events occurring during the assessment
Time Frame
Baseline
Title
Rate of falls
Description
Number of falls during the prevoius 6 months
Time Frame
During the previous 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Banfi, MD
Organizational Affiliation
banfi.giuseppe@fondazionesanraffaele.it
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Galeazzi Orthopedic Hospital
City
Milan
ZIP/Postal Code
20161
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
31574809
Citation
Castellini G, Gianola S, Stucovitz E, Tramacere I, Banfi G, Moja L. Diagnostic test accuracy of an automated device as a screening tool for fall risk assessment in community-residing elderly: A STARD compliant study. Medicine (Baltimore). 2019 Sep;98(39):e17105. doi: 10.1097/MD.0000000000017105.
Results Reference
derived
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A Device for Screening of Fall Risk in the Elderly
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