A Device for Screening of Fall Risk in the Elderly

NCT02655796 | Completed Phase 2 DMC

• 1 other identifier: OAK
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Imbalance; Gait, Unsteady

Keywords

Accidental Falls; Risk Assessment; Frail Elderly

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Adverse events

  Baseline

• Serious adverse events

  Baseline

• Rate of falls

  During the previous 6 months

Study Arms (2)

Moderate/High Risk

EXPERIMENTAL

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

Device: OAK

Low Risk

EXPERIMENTAL

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

Device: OAK

Interventions

OAK DEVICE

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

Low Risk; Moderate/High Risk

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Able to walk without walking aids.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

Location

Related Publications (1)

• 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.

  PMID: 31574809 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Banfi, MD

  banfi.giuseppe@fondazionesanraffaele.it

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-02

Locations

IT (1)