ElderlyNCT04330053
Documentation of Fall Incidents and Application of a Fall Prevention Programme for Seniors in Northern Greece
A study testing Experimental in people with Elderly and Accidental Falls, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Elderly, Accidental Falls, Prevention
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2019to 10 Apr 2021
- Phase
- Interventional
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People aged 65 - 80
- Ambulatory people who walk independently or with some walking assistance device
- People with a history of at least one fall in the last 12 months
- People with Timed Up and Go test score minor than 15sec
Who cannot join
- People who were diagnosed with neurodegenerative disease (e.g. Parkinson's disease)
- People who recently had a stroke
- People with decreased ability to communicate (senile dementia etc.)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotle University of Thessaloniki
Thessaloniki, Central Makedonia, 57001
About this study
Official title: A Record of Falls in Seniors in Central Macedonia and an Intervention for Injury Prevention Through Special Exercise Programs for Fall Prevention
Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece, unlike other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a government agency in Greece such as the Elderly Day Care Centers (EDCC) has not yet been possible.
Read the detailed description
Background: Falls in the elderly are a global health problem as they are associated with serious injuries and chronic disability. About 30% of seniors over 65 experience one or more falls each year. Any fall can lead to injury, a long period of immobilization, a decline in the functional level of the elderly, a negative psychological impact and often the elderly can even end up in death. The causes of the falls are multifactorial and are related both to the effects of aging on the human body and to environmental factors. Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece in contrast to other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The combination of balance exercises and strengthening of the core and lower limbs seems to have a positive effect on the elderly in avoiding falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a state body has not yet been possible.
Aim: The purpose of this study is to record the incidence of falls in older people, to inform and educate them on prevention and to study the effect of specialized therapeutic exercise in relation to the usual physiotherapeutic care in reducing the number of falls. Senior people will be selected from the Elderly Day Care Centers for this purpose.
Methods / Design: About 150 elderly people over 65 are expected to participate in this study. Participants will be recruited from 15 Day Care Centers, which will be divided into two groups (intervention and control). All participants will be informed and trained in fall prevention through lectures at the Day Care Center, as well as through the distribution of appropriate audiovisual material. Subsequently, the participants of the intervention group will follow a 6-month OTAGO group exercise program, where seniors will perform exercises three times a week. The control group participants will receive a leaftlet with general exercise (not falls prevention specific). The history of falls, fear of falling, balance and functional ability of participants will be assessed before, during and after the intervention, and will be re-examined 6 months after the intervention.
Expected results: The results of this research will give a first glimpse of the magnitude of the problem of falls in older people in Greece, as data will be collected on the number of episodes, the factors that cause them, the outcome of falls, etc. The effectiveness of targeted exercise programs and in particular of OTAGO in reducing the number of falls and improving the balance and functional capacity of older people will also be explored.
- Conditions
- Elderly, Accidental Falls, Prevention, Exercise
- Being tested
- Experimental, Control
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
- Training will address issues such as: environmental security, identifying hazards that can lead to a fall, psychological support, getting up from a fall, standing techniques and calling for help.
- The exercise program will last for six months and will be based on the OTAGO exercise program, which includes five exercise groups: general warm-up, muscle strengthening exercises, balance exercises, range of motion and stretching exercises. The program will be performed individually or in groups of two people at most and will be conducted once a week in one of the 5 outpatient clinics under the supervision of a specialized OTAGO trainer, while seniors should repeat the exercises twice a week alone at home and also walk twice a week for at least half an hour.
ControlOther
- Information / Education about falls The participants in this group will receive the same information - education as the participants of the 1st group.
- They will be given a leaflet with general gentle exercises (not fall prevention specific) for the home.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Information - Education about falls and Exercise for Fall Prevention Receives: Other: Experimental |
| Control | Active comparator | Information - Education about falls without Exercise for Fall Prevention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CONFbal - GREEK score questionnaire
The CONFbal questionnaire is a tool that assesses the self-esteem of an elderly person associated with the risk of falling. It consists of a 10-item scale, which are summed to give an index of balance confidence. The score ranges from 10 to 30. A higher score indicates lower balance confidence. Τhe questionnaire demonstrates excellent internal consistency and excellent test-retest reliability. The Greek version of the questionnaire CONFbal - GREEK (Billis, et al., 2011) will be used in this study.
Measured: Pre-treatment, Month 6, 12
Changes in Short Falls Efficacy Scale International (Short FES-I) score questionnaire
Short FES-I is a measure of "fear of falling" or, more properly, "concerns about falling", which are suitable for use in research and clinical practice. It is the short version of the Falls Efficacy Scale International (FES-I), comprised of seven questions and is more applicable in clinical practice. The score ranges from 7 to 28. A higher score indicates greater fear of falling. The Greek version of the questioner (Billis, et al., 2011) will be used in this study
Measured: Pre-treatment, Month 6, 12
Changes in 4-Stage Balance Scale test
The 4-Stage Balance Test is an assessment of static balance in four different and increasingly challenging positions - feet together, instep of foot advanced to toe of other foot, foot in front of other foot (tandem), and single leg stance (Lajoie \& Gallagher, 2004). The participant must stand in each position for ten seconds, while the examiner tracks time using a stopwatch. Each of the first three positions is evaluated with the eyes open and closed, while the single leg stance is evaluated only with the eyes open, so each participant is evaluated in a total of seven tests. Each test is scored from four to zero (representing "able to stand for 10 seconds safely" and "needs help to keep from falling" respectively). The final score results from the sum of all seven tests and ranges from zero to 28. A higher score indicates greater static balance ability of the participant. The test has good validity (Marques et al., 2017).
Measured: Pre-treatment, Month 6, 12
Changes in Timed Up and Go test
It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo \& Richardson). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant.
Measured: Pre-treatment, Month 6, 12
Changes in number of falls
Changes in number of falls will be evaluated through a Falls diary which will be completed each month by the elderly
Measured: Pre-treatment, Month 6, 12
Changes in the 30-Second Chair Stand Test
The 30-Second Chair Stand Test is a test for assessing leg strength and endurance in elderly adults. It is part of the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit, which was created by the Centers for Disease Control and Prevention as a screening tool for seniors belonging in the high fall risk group (Stevens, 2013). The test measures the number of times an elderly person can get up from a chair with their arms crossed in front of their trunk (on the opposite shoulder crossed at the wrists) in 30sec. This test was developed to overcome the floor effect of the five or ten repetition sit to stand test in older adults. The test has been characterized by excellent test-retest reliability in a total number of participants: r = 0.89 (95% Confidence interval 0.79-0.93) (Rikli \& Jones, 1999).
Measured: Pre-treatment, Month 6, 12
Changes in Berg Balance scale Test
The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015).
Measured: Pre-treatment, Month 6, 12
Secondary outcomes (1)
Changes in adherence to exercise via Exercise Diary keeping
After the 6 months intervention period the participants of both groups will be asked to continue to perform the specific exercise programs three times per week for a period of six months recording the adherence or not to the exercise programs in a weekly diary while the assessor will collect the data by phone 2-3 times a month.
Measured: Month 7, 8, 9, 10, 11, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Dec 2019
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
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 ElderlyStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An assessor-blind randomized control trial with a duration of six months and a 6-month follow up will be performed in 150 seniors with a history of a previous fall. The participants will be allocated into two groups of 75 persons each (one intervention group and one control group). The first group will receive consulting about home modification for home safety related to fall prevention and training on how to avoid a fall and how to act if a fall occurs. Additionally, the first group participants will follow a fall prevention exercise program based on the OTAGO exercise program. The second group (control group) will receive only the consulting and training part excluding the fall prevention exercise program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LYTRAS DIMITRIOS, Aristotle University Of Thessaloniki
- Investigators
- Evaggelos Sykaras, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330053
- Sponsor's protocol ID
- 44338/2020
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lytras D, Sykaras E, Iakovidis P, Komisopoulos C, Chasapis G, Mouratidou C. Effects of a modified Otago exercise program delivered through outpatient physical therapy to community-dwelling older adult fallers in Greece during the COVID-19 pandemic: a controlled, randomized, multicenter trial. Eur Geriatr Med. 2022 Aug;13(4):893-906. doi: 10.1007/s41999-022-00656-y. Epub 2022 May 24.
PubMed 35606677
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Record of Falls in Seniors in Central Macedonia and an Intervention for Injury Prevention Through Special Exercise Programs for Fall Prevention
- ClinicalTrials.gov ID
- NCT04330053
- Acronym / sponsor ID
- 44338/2020
- Conditions
- Elderly, Accidental Falls, Prevention, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 1 Apr 2020 (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.
Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece, unlike other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a government agency in Greece such as the Elderly Day Care Centers (EDCC) has not yet been possible.
Detailed description
Background: Falls in the elderly are a global health problem as they are associated with serious injuries and chronic disability. About 30% of seniors over 65 experience one or more falls each year. Any fall can lead to injury, a long period of immobilization, a decline in the functional level of the elderly, a negative psychological impact and often the elderly can even end up in death. The causes of the falls are multifactorial and are related both to the effects of aging on the human body and to environmental factors. Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece in contrast to other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The combination of balance exercises and strengthening of the core and lower limbs seems to have a positive effect on the elderly in avoiding falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a state body has not yet been possible.
Aim: The purpose of this study is to record the incidence of falls in older people, to inform and educate them on prevention and to study the effect of specialized therapeutic exercise in relation to the usual physiotherapeutic care in reducing the number of falls. Senior people will be selected from the Elderly Day Care Centers for this purpose.
Methods / Design: About 150 elderly people over 65 are expected to participate in this study. Participants will be recruited from 15 Day Care Centers, which will be divided into two groups (intervention and control). All participants will be informed and trained in fall prevention through lectures at the Day Care Center, as well as through the distribution of appropriate audiovisual material. Subsequently, the participants of the intervention group will follow a 6-month OTAGO group exercise program, where seniors will perform exercises three times a week. The control group participants will receive a leaftlet with general exercise (not falls prevention specific). The history of falls, fear of falling, balance and functional ability of participants will be assessed before, during and after the intervention, and will be re-examined 6 months after the intervention.
Expected results: The results of this research will give a first glimpse of the magnitude of the problem of falls in older people in Greece, as data will be collected on the number of episodes, the factors that cause them, the outcome of falls, etc. The effectiveness of targeted exercise programs and in particular of OTAGO in reducing the number of falls and improving the balance and functional capacity of older people will also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An assessor-blind randomized control trial with a duration of six months and a 6-month follow up will be performed in 150 seniors with a history of a previous fall. The participants will be allocated into two groups of 75 persons each (one intervention group and one control group). The first group will receive consulting about home modification for home safety related to fall prevention and training on how to avoid a fall and how to act if a fall occurs. Additionally, the first group participants will follow a fall prevention exercise program based on the OTAGO exercise program. The second group (control group) will receive only the consulting and training part excluding the fall prevention exercise program.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalInformation - Education about falls and Exercise for Fall Prevention |
| Control | Active comparator | Other: ControlInformation - Education about falls without Exercise for Fall Prevention |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People aged 65 - 80
- Ambulatory people who walk independently or with some walking assistance device
- People with a history of at least one fall in the last 12 months
- People with Timed Up and Go test score minor than 15sec
Key exclusion criteria (3 listed)
- People who were diagnosed with neurodegenerative disease (e.g. Parkinson's disease)
- People who recently had a stroke
- People with decreased ability to communicate (senile dementia etc.)
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 |
|---|---|---|
| Experimental* Training will address issues such as: environmental security, identifying hazards that can lead to a fall, psychological support, getting up from a fall, standing techniques and calling for help. * The exercise program will last for six months and will be based on the OTAGO exercise program, which includes five exercise groups: general warm-up, muscle strengthening exercises, balance exercises, range of motion and stretching exercises. The program will be performed individually or in groups of two people at most and will be conducted once a week in one of the 5 outpatient clinics under the supervision of a specialized OTAGO trainer, while seniors should repeat the exercises twice a week alone at home and also walk twice a week for at least half an hour. | Other | Experimental |
| Control* Information / Education about falls The participants in this group will receive the same information - education as the participants of the 1st group. * They will be given a leaflet with general gentle exercises (not fall prevention specific) for the home. | Other | Control |
Primary outcome
Changes in CONFbal - GREEK score questionnaire
Time frame: Pre-treatment, Month 6, 12
The CONFbal questionnaire is a tool that assesses the self-esteem of an elderly person associated with the risk of falling. It consists of a 10-item scale, which are summed to give an index of balance confidence. The score ranges from 10 to 30. A higher score indicates lower balance confidence. Τhe questionnaire demonstrates excellent internal consistency and excellent test-retest reliability. The Greek version of the questionnaire CONFbal - GREEK (Billis, et al., 2011) will be used in this study.
Changes in Short Falls Efficacy Scale International (Short FES-I) score questionnaire
Time frame: Pre-treatment, Month 6, 12
Short FES-I is a measure of "fear of falling" or, more properly, "concerns about falling", which are suitable for use in research and clinical practice. It is the short version of the Falls Efficacy Scale International (FES-I), comprised of seven questions and is more applicable in clinical practice. The score ranges from 7 to 28. A higher score indicates greater fear of falling. The Greek version of the questioner (Billis, et al., 2011) will be used in this study
Changes in 4-Stage Balance Scale test
Time frame: Pre-treatment, Month 6, 12
The 4-Stage Balance Test is an assessment of static balance in four different and increasingly challenging positions - feet together, instep of foot advanced to toe of other foot, foot in front of other foot (tandem), and single leg stance (Lajoie \& Gallagher, 2004). The participant must stand in each position for ten seconds, while the examiner tracks time using a stopwatch. Each of the first three positions is evaluated with the eyes open and closed, while the single leg stance is evaluated only with the eyes open, so each participant is evaluated in a total of seven tests. Each test is scored from four to zero (representing "able to stand for 10 seconds safely" and "needs help to keep from falling" respectively). The final score results from the sum of all seven tests and ranges from zero to 28. A higher score indicates greater static balance ability of the participant. The test has good validity (Marques et al., 2017).
Changes in Timed Up and Go test
Time frame: Pre-treatment, Month 6, 12
It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo \& Richardson). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant.
Changes in number of falls
Time frame: Pre-treatment, Month 6, 12
Changes in number of falls will be evaluated through a Falls diary which will be completed each month by the elderly
Changes in the 30-Second Chair Stand Test
Time frame: Pre-treatment, Month 6, 12
The 30-Second Chair Stand Test is a test for assessing leg strength and endurance in elderly adults. It is part of the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit, which was created by the Centers for Disease Control and Prevention as a screening tool for seniors belonging in the high fall risk group (Stevens, 2013). The test measures the number of times an elderly person can get up from a chair with their arms crossed in front of their trunk (on the opposite shoulder crossed at the wrists) in 30sec. This test was developed to overcome the floor effect of the five or ten repetition sit to stand test in older adults. The test has been characterized by excellent test-retest reliability in a total number of participants: r = 0.89 (95% Confidence interval 0.79-0.93) (Rikli \& Jones, 1999).
Changes in Berg Balance scale Test
Time frame: Pre-treatment, Month 6, 12
The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015).
1 secondary outcome
Changes in adherence to exercise via Exercise Diary keeping
Time frame: Month 7, 8, 9, 10, 11, 12
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 15 Apr 2021.
- Derived from this study: PubMed 35606677Lytras D, Sykaras E, Iakovidis P, Komisopoulos C, Chasapis G, Mouratidou C. Effects of a modified Otago exercise program delivered through outpatient physical therapy to community-dwelling older adult fallers in Greece during the COVID-19 pandemic: a controlled, randomized, multicenter trial. Eur Geriatr Med. 2022 Aug;13(4):893-906. doi: 10.1007/s41999-022-00656-y. Epub 2022 May 24.
- 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.
Evaggelos Sykaras study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Elderly and Accidental Falls, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 3 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 15 Apr 2021. 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 Greece. 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?
Changes in CONFbal - GREEK score questionnaire (time frame: Pre-treatment, Month 6, 12). The study lists 7 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 NCT04330053, 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 15 Apr 2021.