Balance DisordersEPIBASNCT06965660
Population Cohort Set-up for the Epidemiological Assessment of Balance Disorders in Elderly People
An observational study of Balance Disorders and Accidental Falls, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
As people age, it becomes more common to experience balance problems. These issues can increase the risk of falling, which may lead to serious health consequences and loss of independence. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Disorders, Accidental Falls, Frailty
- How many people
- 1,300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The target population is an age-based cohort of people aged 65-75 living in Mataró. This age range was selected to find individuals who do not yet have BDs, enabling the calculation of the incidence. According to the 2017 municipal register, and the population's age structure, there are 2,215 people in this age range. A total of 1,316 people will be randomly selected to form a sample stratified by gender and age from the Primary Care Information System (SIAP) database, which includes health cardholders. The SIAP is not as exhaustive or up-to-date as the population census. This register includes any individual ascribed to a primary care center (covering nearly the entire population), regardless of whether or not they have used this health service and whether they are healthy or ill. Our research team will contact the selected participants using the phone number registered in the SIAP and invite them to take part in the study.
Who may be able to join
- Aged 65-75.
- Reside in Mataró.
- Able to walk independently, with or without technical assistance.
Who cannot join
- Unable to walk independently.
- Terminal illness or severe cognitive decline.
- Incompetence in Catalan or Spanish.
- Lack of phone access.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina - USR Metropolitan North.
Mataró, Barcelona, 08303
About this study
Official title: Prevalence and Burden of Balance Disorders in Community-dwelling Older Adults: A Population-based Study Protocol
As people age, it becomes more common to experience balance problems. These issues can increase the risk of falling, which may lead to serious health consequences and loss of independence. While many studies have looked at falls in older adults, there is still limited information about how many people actually have balance disorders, how these disorders develop over time, and which factors might help detect them early-before a fall happens.
This clinical study aims to understand how common balance disorders are among older adults aged 65 to 75, how they change over time, and which simple, accessible tools might help us predict who is at risk. The study will include over 1,300 participants living in Mataró (Barcelona, Spain), who will be followed for a period of 18 months.
Read more
Participants will undergo a series of assessments to measure their balance, leg strength, and general health. One key test is posturography, an advanced method that evaluates how well a person can maintain balance. In addition, the study will explore the use of a simple tool-the Nintendo Wii™ Balance Board-as a low-cost way to detect balance issues. Retinal photographs will also be taken to study the small blood vessels in the eye, which may reflect changes in brain circulation that affect balance. Lastly, a tool called the Health Assessment Tool (HAT) will be used to assess participants' overall physical and cognitive function.
The study hypothesizes that certain indicators-such as leg strength, changes in retinal blood vessels, balance performance using tools like the Wii™, and overall health assessments (HAT)-can help predict who is at greater risk for balance problems and falls. The study also explores whether posturography, as a gold-standard method, can reveal how balance disorders are related to the risk and consequences of falling.
Detecting balance problems early can help prevent falls, reduce the risk of injury, and support older adults in maintaining their independence. This study may help identify easy and effective methods to screen for balance disorders, improving quality of life for older adults and reducing the personal and healthcare costs associated with falls.
Read the detailed description
Background:
Poor balance leads to falls, which can result in loss of personal autonomy and reduced quality of life. Epidemiological studies on balance disorders (BDs) remain scarce. It is essential to determine the prevalence and incidence of BDs and to identify potential markers that facilitate their detection and monitoring in an accessible and practical way.
Aims:
- To assess the prevalence of BDs in men and women aged 65-72 using posturography and a variety of balance tests, and to monitor the annual incidence of BDs.
- To analyze the relationship between retinal microvasculature abnormalities and balance impairments.
- To evaluate the effectiveness of the Wii Balance Board™ as a tool for balance assessment compared to posturography.
- To explore whether knee extensor strength and a composite measure of physical and cognitive function can serve as predictors of BDs and fall risk.
- To externally validate the Health Assessment Tool (HAT scale) in the Spanish population.
Methods:
This is a two-phase observational study.
- Phase I: Descriptive, cross-sectional.
- Phase II: Cohort follow-up at 18 months. A total of 1,316 individuals aged 65-75 residing in Mataró (Barcelona, Spain) will be included, excluding those unable to walk independently. Participants will undergo posturography, retinal imaging, knee extensor strength measurement, and a battery of functional tests: Tinetti Test, Timed Up and Go test, Unipedal Stance Test, Short Physical Performance Battery (SPPB), and balance assessment using the Nintendo Wii at baseline and at the end of follow-up. Bimonthly phone calls will be conducted to detect fall events.
Applicability and relevance:
BDs are often underdiagnosed and undertreated. Current awareness of the problem is limited. Enhancing knowledge in this field is crucial to prevent the loss of functional autonomy and to develop targeted preventive strategies for those at highest risk of falls. This will allow for a more efficient and evidence-based approach to this prevalent geriatric syndrome.
- Conditions
- Balance Disorders, Accidental Falls, Frailty, Aging
- Keywords
- Postural balance, Balance disorders, Falls, Posturography, Retinal microvasculature, Nintendo Wii Balance Board™, Knee extensor strength, Aging, Prevalence, Health Assessment Tool (HAT), Cognitive function, Epidemiology
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Age-based cohort of people aged 65-75 living in Mataró, Spain | Eligibility criteria: * Aged 65-75. * Reside in Mataró. * Able to walk independently, with or without technical assistance. Exclusion criteria: * Unable to walk independently. * Terminal illness or severe cognitive decline. * Incompetence in Catalan or Spanish. * Lack of phone access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturography
Static posturography measures the displacement of the center of pressure while standing on a force platform. Greater sway indicates poorer balance control. Also looks at dynamic stability.
The balance assessment is based on the comparison of the parameters that best discriminate the pathology of the general population with those obtained from patterns of normality segmented by age (database of the Institute of Biomechanics of Valencia). Ratings are displayed in percentages, so that results other than 100% reflect discrepancy with respect to normal values. It is considered pathological when the results are less than 95%, indicating that these subjects are more likely to present an alteration in the studied system. Pathological values for the limits of stability are considered to be below 85%.
Measured: Baseline and 18-month follow-up
Unipedal Stance Test
The test measures whether the participant is able to stand on one leg without support for 5 seconds.
Measured: Baseline and 18-month follow-up
Timed Up and Go (TUG) Test
Time in seconds taken to rise from a chair, walk 3 meters, turn around, return, and sit down again. Shorter times indicate better functional mobility and lower fall risk.
Measured: Baseline and 18-month follow-up
Tinetti Test
The Tinetti assesses gait and balance. It consists of two components: balance (maximum 16 points) and gait (maximum 12 points), for a total score ranging from 0 to 28 points. Higher scores indicate better balance and gait performance, and lower risk of falls.
Measured: Baseline and 18-month follow-up
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery is an objective tool for measuring functional capacity, balance, and lower limb strength in adults over 65 years old. The test includes three different domains to assess functional mobility: gait, sit-to-stand, and balance. A score below 8 indicates mobility and physical exercise limitations and is associated with a higher risk of mobility disability and, consequently, a higher risk of falls. A score of 8 or higher is considered within the normal range.
Measured: Baseline and 18-month follow-up
Balance Assessment Using the Nintendo Wii Console
This includes the test of the gimp leg and center of gravity assessment, as well as Romberg Test variants: Eyes Open (REO), Eyes Closed (REC), and on Foam Pad (RuFP), as performed in the posturography test. The Nintendo Wii provides accurate measures of body center of pressure (COP), an important metric for balance stability assessment approximating the body's center of mass. The Romberg test assesses gait disturbance caused by abnormal proprioception, disequilibrium from central vertigo, and peripheral vertigo. Patients is asked to stand with feet together, arms next to the body, first with eyes open and then closed. The patient tries to maintain his balance. The test is scored by counting the seconds the patient can stand with eyes closed.
Measured: Baseline and 18-month follow-up
Muscle Strength of Lower Limbs
Measurement of force in kilograms of the lower extremities using a hand-held dynamometer or similar device. Higher values indicate greater muscle strength
Measured: Baseline and 18-month follow-up
Gait Speed
Measurement of usual walking speed (in seconds) over a distance of 6 meters. Higher speeds indicate better functional mobility.
Measured: Baseline, 6-month follow-up, and 18-month follow-up
Physical activity measured using the abbreviated Spanish version of the Minnesota Leisure-Time Physical Activity Questionnaire (VREM)
The VREM is a short version in Spanish of the Minnesota Leisure Time Physical Activity Questionnaire (CAFM). It is a tool designed to assess the quality and quantity of physical activity performed during leisure time. It consists of 6 items that evaluate the physical activity performed in the last month, taking into account only the activities performed during free time.
The energy expenditure is quantified in MET-min/14 days by multiplying the METs of each physical activity by its duration (in minutes) by the frequency accumulated in the month prior to the interview and by the months of the year in which the activity was performed. Furthermore, it is divided by 365 days/year and multiplied by 14 days. Then, it is classified according to the energetic cast:
- Very active: Energy index higher than 5,000 METs-min/14 days.
- Active: Energy index between 3,000 and 4,999 METs-min/14 days.
- Moderately active: Energy index between 1,250 and 2,999 METs-min/14 days.
- Sedentary: Energy index
Measured: Baseline and 18-month follow-up
Lawton-Brody Instrumental Activities of Daily Living (IADL)
The scale evaluates complex daily activities (e.g., cooking, managing finances). Scores range from 0 (low function, dependent) to 8 (high function, independent). Higher scores indicate better functional capacity.
Measured: Baseline, 6-month follow-up, and 18-month follow-up
Barthel Index of Activities of Daily Living (ADL)
Assesses performance in basic activities such as bathing, dressing, and feeding. Scores range from 0 to 100. Higher scores indicate greater independence.
Measured: Baseline, 6-month follow-up, and 18-month follow-up
Secondary outcomes (2)
Health Assessment Tool (HAT)
Health status will be assessed using the Health Assessment Tool (HAT), a composite measure integrating the following five health dimensions:
- Physical function, assessed by gait speed (measured over 4 meters);
- Cognitive function, assessed by the Mini-Mental State Examination (MMSE), ranging from 0 to 30, with higher scores indicating better cognitive function;
- Chronic morbidity, determined by the number of diagnosed chronic conditions recorded using the ICD-10 classification system;
- Mild disability, assessed using the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale, excluding household tasks to reduce gender bias;
- Severe disability, assessed using the Barthel Index for basic activities of daily living (ADLs), focusing on five essential self-care tasks (bathing, toileting, transferring, eating, and dressing).
These dimensions will be combined to generate a composite health status profile, according to the HAT methodology.
Measured: 6-month follow-up
Retinography
Retinal images will be analyzed to assess microvascular parameters using two software tools:
- IMEDOS Vessel Map software (IMEDOS Systems UG, Germany) will be used to measure retinal vessel diameters and calculate central retinal arteriolar equivalent (CRAE), central retinal venular equivalent (CRVE), and arteriolar-to-venular ratio (AVR).
- SIRIUS software (University of A Coruña) will be used to calculate retinal vessel tortuosity and arteriovenous (A/V) ratio.
These parameters serve as non-invasive biomarkers of microvascular health.
Measured: Baseline and 18-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Apr 2022
- Primary completion10 Apr 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Balance DisordersStudies 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
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Fundació Tecnocampus Mataró-Maresme, Fundació Institut Germans Trias i Pujol, Universidade da Coruña
- Responsible party
- Principal investigator, Pilar Montero Alía, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965660
- Sponsor's protocol ID
- PI20/00406
- Other IDs
- PI20/00406
- Acronym
- EPIBAS
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montero-Alia P, Fornes-Reynes A, Rodriguez-Perez MC, Dacosta-Aguayo R, Miralles-Basseda R, Jimenez-Pascua T, Pascual-Bielsa J, Dura Mata MJ, Molleda-Marzo MM, Ramos-Garcia L, Lopez-Linfante VM, Dolade-Botias M, Alvarez-Alvarez M, Jimenez-Gonzalez M, Montero-Alia JJ, Suarez-Hervella A, Diez-Fadrique G, Moix-Juan Torres M, De Gea-Espinosa L, Lamonja-Vicente N, Mas-Pons L, Leon-Prieto C, Calderon-Larranaga A, Manresa-Dominguez JM, Toran-Monserrat P. Prevalence and incidence of balance disorders in community-dwelling older adults: Protocol for the EPIBAS epidemiological balance study. PLoS One. 2026 Jun 5;21(6):e0346698. doi: 10.1371/journal.pone.0346698. eCollection 2026.
PubMed 42247357
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Burden of Balance Disorders in Community-dwelling Older Adults: A Population-based Study Protocol
- ClinicalTrials.gov ID
- NCT06965660
- Acronym / sponsor ID
- EPIBAS / PI20/00406
- Conditions
- Balance Disorders, Accidental Falls, Frailty, Aging
- Keywords
- Postural balance, Balance disorders, Falls, Posturography, Retinal microvasculature, Nintendo Wii Balance Board™, Knee extensor strength, Aging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Fundació Tecnocampus Mataró-Maresme, Fundació Institut Germans Trias i Pujol, Universidade da Coruña
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 11 May 2025 (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.
As people age, it becomes more common to experience balance problems. These issues can increase the risk of falling, which may lead to serious health consequences and loss of independence. While many studies have looked at falls in older adults, there is still limited information about how many people actually have balance disorders, how these disorders develop over time, and which factors might help detect them early-before a fall happens.
This clinical study aims to understand how common balance disorders are among older adults aged 65 to 75, how they change over time, and which simple, accessible tools might help us predict who is at risk. The study will include over 1,300 participants living in Mataró (Barcelona, Spain), who will be followed for a period of 18 months.
Participants will undergo a series of assessments to measure their balance, leg strength, and general health. One key test is posturography, an advanced method that evaluates how well a person can maintain balance. In addition, the study will explore the use of a simple tool-the Nintendo Wii™ Balance Board-as a low-cost way to detect balance issues. Retinal photographs will also be taken to study the small blood vessels in the eye, which may reflect changes in brain circulation that affect balance. Lastly, a tool called the Health Assessment Tool (HAT) will be used to assess participants' overall physical and cognitive function.
The study hypothesizes that certain indicators-such as leg strength, changes in retinal blood vessels, balance performance using tools like the Wii™, and overall health assessments (HAT)-can help predict who is at greater risk for balance problems and falls. The study also explores whether posturography, as a gold-standard method, can reveal how balance disorders are related to the risk and consequences of falling.
Detecting balance problems early can help prevent falls, reduce the risk of injury, and support older adults in maintaining their independence. This study may help identify easy and effective methods to screen for balance disorders, improving quality of life for older adults and reducing the personal and healthcare costs associated with falls.
Detailed description
Background:
Poor balance leads to falls, which can result in loss of personal autonomy and reduced quality of life. Epidemiological studies on balance disorders (BDs) remain scarce. It is essential to determine the prevalence and incidence of BDs and to identify potential markers that facilitate their detection and monitoring in an accessible and practical way.
Aims:
- To assess the prevalence of BDs in men and women aged 65-72 using posturography and a variety of balance tests, and to monitor the annual incidence of BDs.
- To analyze the relationship between retinal microvasculature abnormalities and balance impairments.
- To evaluate the effectiveness of the Wii Balance Board™ as a tool for balance assessment compared to posturography.
- To explore whether knee extensor strength and a composite measure of physical and cognitive function can serve as predictors of BDs and fall risk.
- To externally validate the Health Assessment Tool (HAT scale) in the Spanish population.
Methods:
This is a two-phase observational study.
- Phase I: Descriptive, cross-sectional.
- Phase II: Cohort follow-up at 18 months. A total of 1,316 individuals aged 65-75 residing in Mataró (Barcelona, Spain) will be included, excluding those unable to walk independently. Participants will undergo posturography, retinal imaging, knee extensor strength measurement, and a battery of functional tests: Tinetti Test, Timed Up and Go test, Unipedal Stance Test, Short Physical Performance Battery (SPPB), and balance assessment using the Nintendo Wii at baseline and at the end of follow-up. Bimonthly phone calls will be conducted to detect fall events.
Applicability and relevance:
BDs are often underdiagnosed and undertreated. Current awareness of the problem is limited. Enhancing knowledge in this field is crucial to prevent the loss of functional autonomy and to develop targeted preventive strategies for those at highest risk of falls. This will allow for a more efficient and evidence-based approach to this prevalent geriatric syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age-based cohort of people aged 65-75 living in Mataró, Spain | – | –Eligibility criteria: * Aged 65-75. * Reside in Mataró. * Able to walk independently, with or without technical assistance. Exclusion criteria: * Unable to walk independently. * Terminal illness or severe cognitive decline. * Incompetence in Catalan or Spanish. * Lack of phone access |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The target population is an age-based cohort of people aged 65-75 living in Mataró. This age range was selected to find individuals who do not yet have BDs, enabling the calculation of the incidence. According to the 2017 municipal register, and the population's age structure, there are 2,215 people in this age range. A total of 1,316 people will be randomly selected to form a sample stratified by gender and age from the Primary Care Information System (SIAP) database, which includes health cardholders. The SIAP is not as exhaustive or up-to-date as the population census. This register includes any individual ascribed to a primary care center (covering nearly the entire population), regardless of whether or not they have used this health service and whether they are healthy or ill. Our research team will contact the selected participants using the phone number registered in the SIAP and invite them to take part in the study.
Key inclusion criteria (3 listed)
- Aged 65-75.
- Reside in Mataró.
- Able to walk independently, with or without technical assistance.
Key exclusion criteria (4 listed)
- Unable to walk independently.
- Terminal illness or severe cognitive decline.
- Incompetence in Catalan or Spanish.
- Lack of phone access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Posturography
Time frame: Baseline and 18-month follow-up
Static posturography measures the displacement of the center of pressure while standing on a force platform. Greater sway indicates poorer balance control. Also looks at dynamic stability. The balance assessment is based on the comparison of the parameters that best discriminate the pathology of the general population with those obtained from patterns of normality segmented by age (database of the Institute of Biomechanics of Valencia). Ratings are displayed in percentages, so that results other than 100% reflect discrepancy with respect to normal values. It is considered pathological when the results are less than 95%, indicating that these subjects are more likely to present an alteration in the studied system. Pathological values for the limits of stability are considered to be below 85%.
Unipedal Stance Test
Time frame: Baseline and 18-month follow-up
The test measures whether the participant is able to stand on one leg without support for 5 seconds.
Timed Up and Go (TUG) Test
Time frame: Baseline and 18-month follow-up
Time in seconds taken to rise from a chair, walk 3 meters, turn around, return, and sit down again. Shorter times indicate better functional mobility and lower fall risk.
Tinetti Test
Time frame: Baseline and 18-month follow-up
The Tinetti assesses gait and balance. It consists of two components: balance (maximum 16 points) and gait (maximum 12 points), for a total score ranging from 0 to 28 points. Higher scores indicate better balance and gait performance, and lower risk of falls.
Short Physical Performance Battery (SPPB)
Time frame: Baseline and 18-month follow-up
The Short Physical Performance Battery is an objective tool for measuring functional capacity, balance, and lower limb strength in adults over 65 years old. The test includes three different domains to assess functional mobility: gait, sit-to-stand, and balance. A score below 8 indicates mobility and physical exercise limitations and is associated with a higher risk of mobility disability and, consequently, a higher risk of falls. A score of 8 or higher is considered within the normal range.
Balance Assessment Using the Nintendo Wii Console
Time frame: Baseline and 18-month follow-up
This includes the test of the gimp leg and center of gravity assessment, as well as Romberg Test variants: Eyes Open (REO), Eyes Closed (REC), and on Foam Pad (RuFP), as performed in the posturography test. The Nintendo Wii provides accurate measures of body center of pressure (COP), an important metric for balance stability assessment approximating the body's center of mass. The Romberg test assesses gait disturbance caused by abnormal proprioception, disequilibrium from central vertigo, and peripheral vertigo. Patients is asked to stand with feet together, arms next to the body, first with eyes open and then closed. The patient tries to maintain his balance. The test is scored by counting the seconds the patient can stand with eyes closed.
Muscle Strength of Lower Limbs
Time frame: Baseline and 18-month follow-up
Measurement of force in kilograms of the lower extremities using a hand-held dynamometer or similar device. Higher values indicate greater muscle strength
Gait Speed
Time frame: Baseline, 6-month follow-up, and 18-month follow-up
Measurement of usual walking speed (in seconds) over a distance of 6 meters. Higher speeds indicate better functional mobility.
Physical activity measured using the abbreviated Spanish version of the Minnesota Leisure-Time Physical Activity Questionnaire (VREM)
Time frame: Baseline and 18-month follow-up
The VREM is a short version in Spanish of the Minnesota Leisure Time Physical Activity Questionnaire (CAFM). It is a tool designed to assess the quality and quantity of physical activity performed during leisure time. It consists of 6 items that evaluate the physical activity performed in the last month, taking into account only the activities performed during free time. The energy expenditure is quantified in MET-min/14 days by multiplying the METs of each physical activity by its duration (in minutes) by the frequency accumulated in the month prior to the interview and by the months of the year in which the activity was performed. Furthermore, it is divided by 365 days/year and multiplied by 14 days. Then, it is classified according to the energetic cast: * Very active: Energy index higher than 5,000 METs-min/14 days. * Active: Energy index between 3,000 and 4,999 METs-min/14 days. * Moderately active: Energy index between 1,250 and 2,999 METs-min/14 days. * Sedentary: Energy index
Lawton-Brody Instrumental Activities of Daily Living (IADL)
Time frame: Baseline, 6-month follow-up, and 18-month follow-up
The scale evaluates complex daily activities (e.g., cooking, managing finances). Scores range from 0 (low function, dependent) to 8 (high function, independent). Higher scores indicate better functional capacity.
Barthel Index of Activities of Daily Living (ADL)
Time frame: Baseline, 6-month follow-up, and 18-month follow-up
Assesses performance in basic activities such as bathing, dressing, and feeding. Scores range from 0 to 100. Higher scores indicate greater independence.
2 secondary outcomes
Health Assessment Tool (HAT)
Time frame: 6-month follow-up
Retinography
Time frame: Baseline and 18-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42247357Montero-Alia P, Fornes-Reynes A, Rodriguez-Perez MC, Dacosta-Aguayo R, Miralles-Basseda R, Jimenez-Pascua T, Pascual-Bielsa J, Dura Mata MJ, Molleda-Marzo MM, Ramos-Garcia L, Lopez-Linfante VM, Dolade-Botias M, Alvarez-Alvarez M, Jimenez-Gonzalez M, Montero-Alia JJ, Suarez-Hervella A, Diez-Fadrique G, Moix-Juan Torres M, De Gea-Espinosa L, Lamonja-Vicente N, Mas-Pons L, Leon-Prieto C, Calderon-Larranaga A, Manresa-Dominguez JM, Toran-Monserrat P. Prevalence and incidence of balance disorders in community-dwelling older adults: Protocol for the EPIBAS epidemiological balance study. PLoS One. 2026 Jun 5;21(6):e0346698. doi: 10.1371/journal.pone.0346698. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Balance Disorders and Accidental Falls, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Posturography (time frame: Baseline and 18-month follow-up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06965660, which also lists 1 linked publication.
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 11 May 2025.