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

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.

Study Overview

• Status: Completed
• Conditions: Aging; Equilibrium; Disorder, Labyrinth
• Intervention / Treatment: Diagnostic test: instrumental description of the subject's center of gravity (COG) sway

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).

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ospedale Maggiore Policlinico
  • Lombardia
    • Milano, Lombardia, Italy, 20145
      • Istituto Auxologico Italiano, IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Balance evaluation; patient's balance is evaluated with instrumental posturography	Diagnostic test: instrumental 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	instrumental evaluation is performed at enrollment;

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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® .	instrumental evaluation is performed at enrollment
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.	instrumental evaluation is performed at enrollment
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	Instrumental evaluation is repeated two weeks after enrollment

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Study Chair: LAURA PERUCCA, MD, ISTITUTO AUXOLOGICO ITALIANO IRCCS - UNIVERSITA DEGLI STUDI DI MILANO

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (ACTUAL): February 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: aging; postural balance; posturography; normative data; EquiTest®; Sensory Organization Test
• Other Study ID Numbers: 24C402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes