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Clinical Trials/NCT04773496
NCT04773496
Completed
Not Applicable

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

Istituto Auxologico Italiano2 sites in 1 country63 target enrollmentMarch 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Equilibrium; Disorder, Labyrinth
Sponsor
Istituto Auxologico Italiano
Enrollment
63
Locations
2
Primary Endpoint
Normative Data for Sensory Organization Test with EquiTest® System in subjects aged 80yrs and over
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
March 1, 2016
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • 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)
  • Normative Data for Motor Control Test and Adaptation Test with EquiTest® System in subjects aged 80yrs and over(instrumental evaluation is performed at enrollment)

Study Sites (2)

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