A Device for Screening of Fall Risk in the Elderly

• Sponsor: Istituto Ortopedico Galeazzi (Other)
• Overall Status: Completed
• CT.gov ID: NCT02655796
• Collaborator: (none)
• Enrollment: 184
• Location: 1
• Arms: 2
• Actual Duration (Months): 18
• Patients Per Site Per Month: 10.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postural Imbalance; Gait, Unsteady	Device: OAK	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. OAK failures in the fall risk assessment [Baseline]

   Proportion of participants for which the OAK device is not able to provide a fall risk assessment

2. OAK sensitivity in the fall risk assessment [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

Secondary Outcome Measures

1. Adverse events [Baseline]

   Adverse events occurring during the assessment

2. Serious adverse events [Baseline]

   Serious adverse events occurring during the assessment

3. Rate of falls [During the previous 6 months]

   Number of falls during the prevoius 6 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Galeazzi Orthopedic Hospital	Milan		Italy	20161

Sponsors and Collaborators

• Istituto Ortopedico Galeazzi

Investigators

• Principal Investigator: Giuseppe Banfi, MD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Ortopedico Galeazzi
• ClinicalTrials.gov Identifier: NCT02655796
• Other Study ID Numbers: OAK
• First Posted: Jan 14, 2016
• Last Update Posted: Jun 29, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Istituto Ortopedico Galeazzi: Accidental Falls; Risk Assessment; Frail Elderly
• Additional relevant MeSH terms: Gait Disorders, Neurologic

Study Results

No Results Posted as of Jun 29, 2017