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Completed

NCT Number: NCT02655796

A Device for Screening of Fall Risk in the Elderly

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.

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Key information

Conditions

Postural Imbalance Gait Disorders, Neurologic Gait, Unsteady Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OAK

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Adverse events

    Time frame: Baseline

    Adverse events occurring during the assessment

  2. Serious adverse events

    Time frame: Baseline

    Serious adverse events occurring during the assessment

  3. Rate of falls

    Time frame: During the previous 6 months

    Number of falls during the prevoius 6 months

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 14, 2016
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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