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

NCT04773496 | Completed

• 1 other identifier: 24C402
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Equilibrium; Disorder, Labyrinth; Aging

Keywords

normative data; postural balance; posturography; EquiTest®; Sensory Organization Test; aging

Outcome Measures

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.

  instrumental evaluation is performed at enrollment;

Secondary Outcomes (3)

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

  instrumental evaluation is performed at enrollment

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

  instrumental evaluation is performed at enrollment

• Reliability of the measures (measures stability)

  Instrumental evaluation is repeated two weeks after enrollment

Study Arms (1)

Balance evaluation

patient's balance is evaluated with instrumental posturography

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

Interventions

instrumental description of the subject's center of gravity (COG) sway DIAGNOSTIC_TEST

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

Balance evaluation

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (2)

Istituto Auxologico Italiano, Irccs

Milan, Lombardy, 20145, Italy

Location

Fondazione Irccs Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Study Officials

• LAURA PERUCCA, MD

  ISTITUTO AUXOLOGICO ITALIANO IRCCS - UNIVERSITA DEGLI STUDI DI MILANO

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 26, 2021
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (2)