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

Aging Clinical Trial

— EQUIOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773496
• Other study ID #: 24C402
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: March 1, 2016

Study information

• Verified date: February 2021
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Equilibrium; Disorder, Labyrinth

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Irccs Ospedale Maggiore Policlinico	Milan
Italy	Istituto Auxologico Italiano, Irccs	Milano	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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