Aging Clinical Trial
— EQUIOLDOfficial title:
Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs
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 |
Verified date | February 2021 |
Source | Istituto Auxologico Italiano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Irccs Ospedale Maggiore Policlinico | Milan | |
Italy | Istituto Auxologico Italiano, Irccs | Milano | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
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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