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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04773496
Other study ID # 24C402
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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