Geriatric PopulationNCT05923385
Are Static and Dynamic Balance Tests A Criteria Showing Cognitive Impairments In the Elderly?
An observational study of Geriatric Population and Balance Problems, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to reveal whether static and dynamic balance tests can be an indicator of deterioration in cognitive impairments in geriatric individuals. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatric Population, Balance Problems
- What is being tested?
- Four Square Step Test
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 12 Feb 2024
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Relative healthy nursing home residents aged 65-85 living in the nursing home will be included in the study.
Who may be able to join
- Relative, healthy elderly individuals aged 65-85 years
- Individuals who do not have neurological / orthopedic problems that will prevent them from performing the test
- Independent elderly individuals in activities of daily living
- Men and women living in a nursing home
- No pre-defined vision and hearing problems
- No history of lower extremity or lumbar spinal surgery
Who cannot join
- Hadkinson's Abbreviated Mental Test less than 7 points
- Presence of defined neurological, orthopedic, systemic (cardiovascular) disease that interferes with walking and mobility
- Presence of defined psychiatric illness
- Having a communication problem
- Presence of using aids for walking
- Use of prostheses or orthoses associated with the lower extremity
- Presence of cognitive, visual or auditory impairment
- Balance-affected individuals with lower extremity disorders
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to reveal whether static and dynamic balance tests can be an indicator of deterioration in cognitive impairments in geriatric individuals.
Read the detailed description
the static and dynamic balance test will be used to predict cognitive impairments in older adults.
- Conditions
- Geriatric Population, Balance Problems
- Being tested
- Four Square Step Test
- Keywords
- geriatria, cognitive status, balance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four Square Step TestDiagnostic test
Also called Timed Get Up and Go Test, One Leg Standing Test (Eyes Open and Eyes Closed), Standardized Mini Mental Test, Functional Reach Test
These are standardized test which will be applied to subjects with pencil, paper and time recorder.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test
The mini mental test is a test that can be administered by a physician, nurse, psychologist or a healthcare professional with a short training. It is a practical mental test in terms of applicability that can show the cognitive level globally. Evaluates cognitive performance quantitatively. It is important in terms of examining the course of dementia cases and their response to treatment in the clinic. There are 11 items in the test gathered around 5 main headings. These items are; Orientation is register memory, attention and calculation, recall and language. The total score is evaluated out of 30. A score of 25 and above is considered normal. Between 10 and 19 is moderate dementia. Between 19-24 refers to early dementia (13,14).
Measured: 5 minutes
Four Step Square Test
The test clinically assesses the ability to change direction while taking a step. At the start of the test, the patient stands in the upper left square (Frame 1) and looks in the direction of Square 2. First, the step sequence is clockwise: Square 1, then Squares 2, 4, and 3. Then the step sequence is counterclockwise: square 3, followed by squares 4, 2, and 1. The physiotherapist demonstrates the test and allows the patient to apply the model to learn the sequence. The test is repeated if the patient fails to complete the sequence successfully or loses balance or touches the cane. Two points are obtained and the better of these two points is recorded. Timed effort begins when the first foot touches the ground at Square 2 and then ends when the patient's second foot touches the ground at Square 1 (15, 16, 17).
Measured: 8 minutes
Timed Up and Get Test
The test assesses functional mobility, balance, and performance in adults 65 years and older. Wearing normal shoes and walking aids, the patient begins the test in a standard seat with his back against the chair, his arms resting on the arms of the chair, and both feet flat on the floor. The patient is instructed to stand up and walk to a line on the ground at a distance of 3 m, turn on the line, walk back to the chair and sit on the chair. The test ends when the patient's hip touches the seat.
The test is repeated twice; The fastest time is recorded. It is classified as mobile for <10 s, general independent for <20 s, and limited mobility for >30 s (15, 16, 18).
Measured: 5 minutes
Secondary outcomes (2)
One Leg Standing Test (Eyes Open and Eyes Closed):
One leg is lifted without touching the standing leg. Initially, the eyes remain open. The patient is instructed to close their eyes and is asked to maintain their balance for 30 seconds. Balance disorder is suspected if the lifted leg touches the support leg, the lifted leg touches the ground, the patient jumps on the standing leg, or touches something for balance. Inability to balance on one leg for 30 seconds during one-leg stance is an indication of decreased balance function. However, the clinical expectation for the ability to balance on one leg decreases with the age of the patient. Healthy individuals aged 60-69 should be able to stand on one leg with their eyes open for at least 5 seconds (19).
Measured: 3 minutes
Functional Reach Test:
The functional reach test, developed by Duncan et al., is a reliable and validated test used in clinical balance measurement. Have the patient raise the right arm 90° while standing in a comfortable position with bare feet and then step with the right arm without stepping and/his balance. During the functional reach test, the physiotherapist observes whether the patient is on the ground with both feet and does not step forward. If one of these behaviors occurs, the patient repeats the test. The Functional Reach Test is repeated three times and the best measurement is recorded. Decreased ability to lie down indicates an increased risk of the patient falling in the future; Values of 15 cm and below indicate a significantly increased risk of falling, and values between 15 and 25 cm indicate a mild fall risk (20).
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start15 Aug 2023
- Primary completion15 Sep 2023
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Geriatric PopulationStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Cavlak, Biruni University
- Investigators
- Guzin Kaya Aytutuldu, PT,PhD., Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923385
- Sponsor's protocol ID
- Biruni Univers
- Status last verified
- Dec 2024
- First submitted
- 19 Jun 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thapa PB, Gideon P, Fought RL, Kormicki M, Ray WA. Comparison of clinical and biomechanical measures of balance and mobility in elderly nursing home residents. J Am Geriatr Soc. 1994 May;42(5):493-500. doi: 10.1111/j.1532-5415.1994.tb04970.x.
PubMed 8176143Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: II. Cardiac and analgesic drugs. J Am Geriatr Soc. 1999 Jan;47(1):40-50. doi: 10.1111/j.1532-5415.1999.tb01899.x.
PubMed 9920228Boyd R, Stevens JA. Falls and fear of falling: burden, beliefs and behaviours. Age Ageing. 2009 Jul;38(4):423-8. doi: 10.1093/ageing/afp053. Epub 2009 May 6.
PubMed 19420144Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644Duncan RP, Earhart GM. Four square step test performance in people with Parkinson disease. J Neurol Phys Ther. 2013 Mar;37(1):2-8. doi: 10.1097/NPT.0b013e31827f0d7a.
PubMed 23364168Shubert TE, McCulloch K, Hartman M, Giuliani CA. The effect of an exercise-based balance intervention on physical and cognitive performance for older adults: a pilot study. J Geriatr Phys Ther. 2010 Oct-Dec;33(4):157-64.
PubMed 21717919Gunendi Z, Ozyemisci-Taskiran O, Demirsoy N. The effect of 4-week aerobic exercise program on postural balance in postmenopausal women with osteoporosis. Rheumatol Int. 2008 Oct;28(12):1217-22. doi: 10.1007/s00296-008-0651-3. Epub 2008 Jul 22.
PubMed 18648815Harrison JK, McArthur KS, Quinn TJ. Assessment scales in stroke: clinimetric and clinical considerations. Clin Interv Aging. 2013;8:201-11. doi: 10.2147/CIA.S32405. Epub 2013 Feb 18.
PubMed 23440256Stevenson TJ, Garland SJ. Standing balance during internally produced perturbations in subjects with hemiplegia: validation of the balance scale. Arch Phys Med Rehabil. 1996 Jul;77(7):656-62. doi: 10.1016/s0003-9993(96)90004-0.
PubMed 8669991Schulz BW, Hart-Hughes S, Gordon MT, Bulat T. Training implications of maximal forces on a computer-controlled and motor-driven leg press by age group, sex, footplate direction, and speed. Exp Gerontol. 2012 Apr;47(4):295-303. doi: 10.1016/j.exger.2012.01.003. Epub 2012 Jan 20.
PubMed 22289381
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Static and Dynamic Balance Tests A Criteria Showing Cognitive Impairments In the Elderly?
- ClinicalTrials.gov ID
- NCT05923385
- Acronym / sponsor ID
- Biruni Univers
- Conditions
- Geriatric Population, Balance Problems
- Keywords
- geriatria, cognitive status, balance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 28 Jun 2023 (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.
The aim of our study is to reveal whether static and dynamic balance tests can be an indicator of deterioration in cognitive impairments in geriatric individuals.
Detailed description
the static and dynamic balance test will be used to predict cognitive impairments in older adults.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Relative healthy nursing home residents aged 65-85 living in the nursing home will be included in the study.
Key inclusion criteria (6 listed)
- Relative, healthy elderly individuals aged 65-85 years
- Individuals who do not have neurological / orthopedic problems that will prevent them from performing the test
- Independent elderly individuals in activities of daily living
- Men and women living in a nursing home
- No pre-defined vision and hearing problems
Key exclusion criteria (8 listed)
- Hadkinson's Abbreviated Mental Test less than 7 points
- Presence of defined neurological, orthopedic, systemic (cardiovascular) disease that interferes with walking and mobility
- Presence of defined psychiatric illness
- Having a communication problem
- Presence of using aids for walking
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 |
|---|---|---|
| Four Square Step TestAlso: Timed Get Up and Go Test, One Leg Standing Test (Eyes Open and Eyes Closed), Standardized Mini Mental Test, Functional Reach TestThese are standardized test which will be applied to subjects with pencil, paper and time recorder. | Diagnostic test | – |
Primary outcome
Standardized Mini Mental Test
Time frame: 5 minutes
The mini mental test is a test that can be administered by a physician, nurse, psychologist or a healthcare professional with a short training. It is a practical mental test in terms of applicability that can show the cognitive level globally. Evaluates cognitive performance quantitatively. It is important in terms of examining the course of dementia cases and their response to treatment in the clinic. There are 11 items in the test gathered around 5 main headings. These items are; Orientation is register memory, attention and calculation, recall and language. The total score is evaluated out of 30. A score of 25 and above is considered normal. Between 10 and 19 is moderate dementia. Between 19-24 refers to early dementia (13,14).
Four Step Square Test
Time frame: 8 minutes
The test clinically assesses the ability to change direction while taking a step. At the start of the test, the patient stands in the upper left square (Frame 1) and looks in the direction of Square 2. First, the step sequence is clockwise: Square 1, then Squares 2, 4, and 3. Then the step sequence is counterclockwise: square 3, followed by squares 4, 2, and 1. The physiotherapist demonstrates the test and allows the patient to apply the model to learn the sequence. The test is repeated if the patient fails to complete the sequence successfully or loses balance or touches the cane. Two points are obtained and the better of these two points is recorded. Timed effort begins when the first foot touches the ground at Square 2 and then ends when the patient's second foot touches the ground at Square 1 (15, 16, 17).
Timed Up and Get Test
Time frame: 5 minutes
The test assesses functional mobility, balance, and performance in adults 65 years and older. Wearing normal shoes and walking aids, the patient begins the test in a standard seat with his back against the chair, his arms resting on the arms of the chair, and both feet flat on the floor. The patient is instructed to stand up and walk to a line on the ground at a distance of 3 m, turn on the line, walk back to the chair and sit on the chair. The test ends when the patient's hip touches the seat. The test is repeated twice; The fastest time is recorded. It is classified as mobile for <10 s, general independent for <20 s, and limited mobility for >30 s (15, 16, 18).
2 secondary outcomes
One Leg Standing Test (Eyes Open and Eyes Closed):
Time frame: 3 minutes
Functional Reach Test:
Time frame: 4 minutes
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 20 Dec 2024.
- Background: PubMed 8176143Thapa PB, Gideon P, Fought RL, Kormicki M, Ray WA. Comparison of clinical and biomechanical measures of balance and mobility in elderly nursing home residents. J Am Geriatr Soc. 1994 May;42(5):493-500. doi: 10.1111/j.1532-5415.1994.tb04970.x.
- Background: PubMed 9920228Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: II. Cardiac and analgesic drugs. J Am Geriatr Soc. 1999 Jan;47(1):40-50. doi: 10.1111/j.1532-5415.1999.tb01899.x.
- Background: PubMed 19420144Boyd R, Stevens JA. Falls and fear of falling: burden, beliefs and behaviours. Age Ageing. 2009 Jul;38(4):423-8. doi: 10.1093/ageing/afp053. Epub 2009 May 6.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- Background: PubMed 23364168Duncan RP, Earhart GM. Four square step test performance in people with Parkinson disease. J Neurol Phys Ther. 2013 Mar;37(1):2-8. doi: 10.1097/NPT.0b013e31827f0d7a.
- Background: PubMed 21717919Shubert TE, McCulloch K, Hartman M, Giuliani CA. The effect of an exercise-based balance intervention on physical and cognitive performance for older adults: a pilot study. J Geriatr Phys Ther. 2010 Oct-Dec;33(4):157-64.
- Background: PubMed 18648815Gunendi Z, Ozyemisci-Taskiran O, Demirsoy N. The effect of 4-week aerobic exercise program on postural balance in postmenopausal women with osteoporosis. Rheumatol Int. 2008 Oct;28(12):1217-22. doi: 10.1007/s00296-008-0651-3. Epub 2008 Jul 22.
- Background: PubMed 23440256Harrison JK, McArthur KS, Quinn TJ. Assessment scales in stroke: clinimetric and clinical considerations. Clin Interv Aging. 2013;8:201-11. doi: 10.2147/CIA.S32405. Epub 2013 Feb 18.
- Background: PubMed 8669991Stevenson TJ, Garland SJ. Standing balance during internally produced perturbations in subjects with hemiplegia: validation of the balance scale. Arch Phys Med Rehabil. 1996 Jul;77(7):656-62. doi: 10.1016/s0003-9993(96)90004-0.
- Background: PubMed 22289381Schulz BW, Hart-Hughes S, Gordon MT, Bulat T. Training implications of maximal forces on a computer-controlled and motor-driven leg press by age group, sex, footplate direction, and speed. Exp Gerontol. 2012 Apr;47(4):295-303. doi: 10.1016/j.exger.2012.01.003. Epub 2012 Jan 20.
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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.
Guzin Kaya Aytutuldu, PT,PhD. study chair
Biruni University
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 Geriatric Population and Balance Problems, run by Biruni University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 20 Dec 2024. 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 Turkey (Türkiye). 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?
Standardized Mini Mental Test (time frame: 5 minutes). The study lists 3 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 NCT05923385, which also lists 10 linked publications.
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 20 Dec 2024.