Osteoporosis, PostmenopausalNCT03832075
Validity of Korebalance Balance System
A study testing Berg Balance Scale, Timed Up and Go Test and Korebalance Balance System in people with Osteoporosis, Postmenopausal and Balance; Distorted, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated with various test and balance systems. This study aims evaluation of the patients with the Korebalance Balance System and balance tests and investigation the validity of the Korebalance Balance System. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Balance; Distorted
- What is being tested?
- Berg Balance Scale, Timed Up and Go Test and Korebalance Balance System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 28 Feb 2019
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having postmenopausal osteoporosis
- No other disease that can cause balance disorder
- Volunteer participation in the study
Who cannot join
- To have a disease that will cause balance disorder,
- Having understanding problem to prevent communication with the patient,
- The lack of motor function to the balance device.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, 34732
Bilinç Doğruöz Karatekin, +905368308709, bilincdogruoz@hotmail.com
Bilinç Doğruöz Karatekin, MD
About this study
Official title: Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients
In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated with various test and balance systems. This study aims evaluation of the patients with the Korebalance Balance System and balance tests and investigation the validity of the Korebalance Balance System.
Read the detailed description
53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance System is a balance assessment and exercise system. The higher the score, the greater the deterioration in the balance. The results of static and dynamic balance evaluation are recorded as score values. In this study, investigators compared Korebalance Balance System, Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1 year, fracture history, history of fracture in mother).
- Conditions
- Osteoporosis, Postmenopausal, Balance; Distorted
- Being tested
- Berg Balance Scale, Timed Up and Go Test, Korebalance Balance System
- Keywords
- osteoporosis, balance, berg balance scale, korebalance balance system
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berg Balance ScaleDiagnostic test
Berg Balance Scale is 14 item scale for detecting balance disorder.
Timed Up and Go TestDiagnostic test
Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.
Korebalance Balance SystemDiagnostic test
Korebalance Balance System evaluates the balance and stability using objective neuro-sensory balance assessment. Static Test requires standing steady \& balancing on the platform, keeping the crosshairs of cursor in the center of the test pattern. The Score indicates the deviation of user's center of gravity from the center of the pattern. Dynamic Test offers a moving cursor that the user "follows". Four patterns are offered: Circle, Square, Infinity and Random. Each pattern is available in three dimensions: Small, Medium and Large; five speeds; Clockwise and Counterclockwise directions.
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal osteoporosis | Experimental | Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder. Receives: Diagnostic Test: Berg Balance Scale; Diagnostic Test: Timed Up and Go Test; Diagnostic Test: Korebalance Balance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients
The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Aug 2018
- Primary completion31 Jan 2019
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832075
- Sponsor's protocol ID
- MedeniyetOP2
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients
- ClinicalTrials.gov ID
- NCT03832075
- Acronym / sponsor ID
- MedeniyetOP2
- Conditions
- Osteoporosis, Postmenopausal, Balance; Distorted
- Keywords
- osteoporosis, balance, berg balance scale, korebalance balance system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 6 Feb 2019 (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.
In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated with various test and balance systems. This study aims evaluation of the patients with the Korebalance Balance System and balance tests and investigation the validity of the Korebalance Balance System.
Detailed description
53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance System is a balance assessment and exercise system. The higher the score, the greater the deterioration in the balance. The results of static and dynamic balance evaluation are recorded as score values. In this study, investigators compared Korebalance Balance System, Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1 year, fracture history, history of fracture in mother).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postmenopausal osteoporosis | Experimental | Diagnostic Test: Berg Balance Scale, Diagnostic Test: Timed Up and Go Test, Diagnostic Test: Korebalance Balance SystemPostmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having postmenopausal osteoporosis
- No other disease that can cause balance disorder
- Volunteer participation in the study
Key exclusion criteria (3 listed)
- To have a disease that will cause balance disorder,
- Having understanding problem to prevent communication with the patient,
- The lack of motor function to the balance device.
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 |
|---|---|---|
| Berg Balance ScaleBerg Balance Scale is 14 item scale for detecting balance disorder. | Diagnostic test | postmenopausal osteoporosis |
| Timed Up and Go TestTimed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults. | Diagnostic test | postmenopausal osteoporosis |
| Korebalance Balance SystemKorebalance Balance System evaluates the balance and stability using objective neuro-sensory balance assessment. Static Test requires standing steady \& balancing on the platform, keeping the crosshairs of cursor in the center of the test pattern. The Score indicates the deviation of user's center of gravity from the center of the pattern. Dynamic Test offers a moving cursor that the user "follows". Four patterns are offered: Circle, Square, Infinity and Random. Each pattern is available in three dimensions: Small, Medium and Large; five speeds; Clockwise and Counterclockwise directions. | Diagnostic test | postmenopausal osteoporosis |
Primary outcome
Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients
Time frame: 6 months
The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berg Balance Scale, Timed Up and Go Test and Korebalance Balance System in people with Osteoporosis, Postmenopausal and Balance; Distorted, run by Istanbul Medeniyet 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 3 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: status not confirmed, as of the sponsor's last update on 6 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients (time frame: 6 months). 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 6 Feb 2019.