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CompletedNCT04773496EQUIOLDUpdated Feb 26, 2021

Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs

An observational study in Equilibrium; Disorder, Labyrinth and Aging, sponsored by Istituto Auxologico Italiano. Completed at 2 sites in Italy. Open to participants aged 80 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-26.

Sponsored by Istituto Auxologico Italiano · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
80 Years and older
Sex
All
01

Study summary

Ageing is known to increase the risk of fall and posturographic stabilometry, both static and dynamic, are useful tools to assess postural stability. To our knowledge, no published normative data for a healthy elderly population are available.

Read the detailed description

The risk of fall rise with ageing and is huge after 85yrs becoming one of the major problems associated with aging.

The computed dynamic posturographic EquiTest® System and Smart BalanceMaster by NeuroCom® International, Inc, Clackamas, OR, USA) provide a qualitative and quantitative analysis of the balance function through the description of the subject's center of gravity (COG) sway.

Sensory Organization Test and Sensory Analysis norms are provided for age groups (20-59; 60-69; 70-79) up to 79yrs, whilst they lack in the international literature for subjects 80+yrs, nonetheless being necessary in the understanding of balance performance from a quantitative point of view.

Subjects 80+yrs are evaluated with EquiTest® System and Smart BalanceMaster to provide mean values and normative data.

In order to assess the reliability of the instrumental evaluation was repeated (T1) two weeks later (±2 days).

02

Conditions studied

  • Equilibrium; Disorder, Labyrinth
  • Aging

Keywords

  • normative data
  • postural balance
  • posturography
  • EquiTest®
  • Sensory Organization Test
  • aging
03

In context

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects 80+yrs were enrolled from the general healthy Italian population.

Inclusion criteria

  • Age older than 79 years
  • Free gait, without aids, for at least 50 mt
  • Cognitive skills allowing the providing of valid informed consent and the understanding of the instructions during clinical and instrumental evaluations

Exclusion criteria

Exclusion Criteria:

  • Pathologies affecting Central Nervous System (i.e., cerebrovascular, neurodegenerative, Alzheimer Disease, Parkinson disease, etc) or vestibulum
  • Previous traumatic brain injury and/or coma lasting more than 24 hrs and occurred within last 20 years
  • Impairment affecting the Peripheral Nervous System i.e., pallesthesia \<4/8
  • Hip or knee joint replacement within the last 10 years
  • Surgeries or pathologies affecting the lower limbs or the spine
  • Pain, acute or chronic
  • Use, within the last 12 hours, of painkillers or drugs interfering with Central Nervous System or balance
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • Balance evaluation

    patient's balance is evaluated with instrumental posturography

    Diagnostic Test: instrumental description of the subject's center of gravity (COG) sway

Interventions

  • Diagnostic testinstrumental description of the subject's center of gravity (COG) sway

    qualitative and quantitative analysis of the balance function through the description of the center of gravity (COG) sway

06

What researchers measure

Primary outcomes

  1. Normative Data for Sensory Organization Test with EquiTest® System in subjects aged 80yrs and over

    Center of gravity sway during posture is evaluated through computed dynamic posturographic EquiTest® System.

    Time frame: instrumental evaluation is performed at enrollment;

Secondary outcomes

  1. Normative Data for Motor Control Test and Adaptation Test with EquiTest® System in subjects aged 80yrs and over

    Motor responses during perturbations posture are evaluated through computed dynamic posturographic EquiTest® .

    Time frame: instrumental evaluation is performed at enrollment

  2. Normative Data for dynamic tests with Smart BalanceMaster® System in subjects aged 80yrs and over

    Center of gravity sway during posture is evaluated through computed dynamic posturographic Smart BalanceMaster® System.

    Time frame: instrumental evaluation is performed at enrollment

  3. Reliability of the measures (measures stability)

    To verify that the instrument yields the same results over multiple trials a second evaluation is performed a second time

    Time frame: Instrumental evaluation is repeated two weeks after enrollment

07

Study locations

2 sites
  • Istituto Auxologico Italiano, Irccs
    Milano, Lombardia 20145, Italy
  • Fondazione Irccs Ospedale Maggiore Policlinico
    Milan, 20122, Italy
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04773496
Lead sponsor
Istituto Auxologico Italiano
Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Sponsor
First posted
Feb 26, 2021
Start date
Mar 1, 2014
Primary completion
Mar 1, 2016
Completion
Mar 1, 2016
Last update
Feb 26, 2021

Study contacts

LAURA PERUCCA, MD
study chair · ISTITUTO AUXOLOGICO ITALIANO IRCCS - UNIVERSITA DEGLI STUDI DI MILANO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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