Equilibrium; Disorder, LabyrinthEQUIOLDNCT04773496
Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs
An observational study of Equilibrium; Disorder, Labyrinth and Aging, run by Istituto Auxologico Italiano at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Equilibrium; Disorder, Labyrinth, Aging
- What is being tested?
- instrumental description of the subject's center of gravity (COG) sway
- How many people
- 63 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2014to 1 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Subjects 80+yrs were enrolled from the general healthy Italian population.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto Auxologico Italiano, Irccs
Milan, Lombardy, 20145
Fondazione Irccs Ospedale Maggiore Policlinico
Milan, 20122
About this study
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.
Read the 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).
- Conditions
- Equilibrium; Disorder, Labyrinth, Aging
- Being tested
- instrumental description of the subject's center of gravity (COG) sway
- Keywords
- normative data, postural balance, posturography, EquiTest®, Sensory Organization Test, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrumental description of the subject's center of gravity (COG) swayDiagnostic test
qualitative and quantitative analysis of the balance function through the description of the center of gravity (COG) sway
| Study group | Role | What they receive |
|---|---|---|
| Balance evaluation | patient's balance is evaluated with instrumental posturography Receives: Diagnostic Test: instrumental description of the subject's center of gravity (COG) sway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: instrumental evaluation is performed at enrollment;
Secondary outcomes (3)
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® .
Measured: instrumental evaluation is performed at enrollment
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.
Measured: instrumental evaluation is performed at enrollment
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
Measured: Instrumental evaluation is repeated two weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Mar 2014
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equilibrium; Disorder, LabyrinthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Sponsor
- Investigators
- LAURA PERUCCA, MD, Study chair, ISTITUTO AUXOLOGICO ITALIANO IRCCS - UNIVERSITA DEGLI STUDI DI MILANO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773496
- Sponsor's protocol ID
- 24C402
- Acronym
- EQUIOLD
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data for Static and Dynamic Posturography (NeuroCom EQUITEST and BALANCE MASTER) in Subjects Older Than 79yrs
- ClinicalTrials.gov ID
- NCT04773496
- Acronym / sponsor ID
- EQUIOLD / 24C402
- Conditions
- Equilibrium; Disorder, Labyrinth, Aging
- Keywords
- normative data, postural balance, posturography, EquiTest®, Sensory Organization Test, aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance evaluation | – | Diagnostic Test: instrumental description of the subject's center of gravity (COG) swaypatient's balance is evaluated with instrumental posturography |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Subjects 80+yrs were enrolled from the general healthy Italian population.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instrumental description of the subject's center of gravity (COG) swayqualitative and quantitative analysis of the balance function through the description of the center of gravity (COG) sway | Diagnostic test | Balance evaluation |
Primary outcome
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.
3 secondary outcomes
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
Normative Data for dynamic tests with Smart BalanceMaster® System in subjects aged 80yrs and over
Time frame: instrumental evaluation is performed at enrollment
Reliability of the measures (measures stability)
Time frame: Instrumental evaluation is repeated two weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAURA PERUCCA, MD study chair
ISTITUTO AUXOLOGICO ITALIANO IRCCS - UNIVERSITA DEGLI STUDI DI MILANO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Equilibrium; Disorder, Labyrinth and Aging, run by Istituto Auxologico Italiano at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative Data for Sensory Organization Test with EquiTest® System in subjects aged 80yrs and over (time frame: instrumental evaluation is performed at enrollment;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.