Clinical trial NCT04773496: Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs
Official title: Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Equilibrium; Disorder, Labyrinth
Aging
Keywords: normative data
postural balance
posturography
EquiTest®
Sensory Organization Test
aging
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2021-02-26
Enrollment: 63
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 80+yrs were enrolled from the general healthy Italian population.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Normative Data for Sensory Organization Test with EquiTest® System in subjects aged 80yrs and over
timeFrame: instrumental evaluation is performed at enrollment;
Secondary outcomes:
measure: Normative Data for Motor Control Test and Adaptation Test with EquiTest® System in subjects aged 80yrs and over
timeFrame: instrumental evaluation is performed at enrollment
measure: Normative Data for dynamic tests with Smart BalanceMaster® System in subjects aged 80yrs and over
timeFrame: instrumental evaluation is performed at enrollment
measure: Reliability of the measures (measures stability)
timeFrame: Instrumental evaluation is repeated two weeks after enrollment
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano, Irccs
state: Lombardia
city: Milan
country: Italy
facility: Fondazione Irccs Ospedale Maggiore Policlinico
Study officials:
affiliation: ISTITUTO AUXOLOGICO ITALIANO IRCCS - UNIVERSITA DEGLI STUDI DI MILANO
name: LAURA PERUCCA, MD
role: STUDY_CHAIR
References: