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OpenTrials
Completed

NCT Number: NCT04773496

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

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.

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano, Irccs, Milan, Lombardy, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Normative Data for Sensory Organization Test with EquiTest® System in subjects aged 80yrs and over

    Time frame: instrumental evaluation is performed at enrollment;

    Center of gravity sway during posture is evaluated through computed dynamic posturographic EquiTest® System.

Secondary outcomes

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

    Time frame: instrumental evaluation is performed at enrollment

    Motor responses during perturbations posture are evaluated through computed dynamic posturographic EquiTest® .

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

    Time frame: instrumental evaluation is performed at enrollment

    Center of gravity sway during posture is evaluated through computed dynamic posturographic Smart BalanceMaster® System.

  3. Reliability of the measures (measures stability)

    Time frame: Instrumental evaluation is repeated two weeks after enrollment

    To verify that the instrument yields the same results over multiple trials a second evaluation is performed a second time

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Registry information

Acronym: EQUIOLD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2021
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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