BalanceNCT03884088
Comparison of Subjective Balance Tests
A study testing Limits of Stability in people with Balance and Posture, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
There is many subjective balance tests to evaluate static and dynamic balance. But, there is no sufficient information about which balance test is the most sensitive test to evaluate balance. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Limits of Stability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Aug 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years,
- To be a volunteer to participate
Who cannot join
- orthopedic problems affecting gait and stance
- visual, auditory, orientational problems that could affect study results,
- Walking with assist device
- Having a neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sensitivity of the Subjective Balance Tests
There is many subjective balance tests to evaluate static and dynamic balance. But, there is no sufficient information about which balance test is the most sensitive test to evaluate balance. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.
Read the detailed description
In the clinical setting, many balance tests are used for evaluating balance in individuals. These tests are utilized to assess both static and dynamic balance. However, sufficient research has not been conducted to decide which subjective balance test is more sensitive than the other tests. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.
- Being tested
- Limits of Stability
- Keywords
- Balance, Limits of Stability, Postural Sway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limits of StabilityOther
Also called Postural Sway test, Berg Balance Scale, Y Balance Test, Romberg Balance Test
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Balance analysis | Experimental | Balance will be assessed by Computerized Balance system and subjective balance tests. Receives: Other: Limits of Stability |
| Control Group: Balance analysis | Active comparator | Balance will be assessed by Computerized Balance system and subjective balance tests. Receives: Other: Limits of Stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of Stability
Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance
Measured: 15 minutes
Postural Sway
Postural sway in centimeters by computerized balance system
Measured: 15 minutes
Secondary outcomes (7)
Timed up and go test
Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance
Measured: 15 minutes
Functional reach test
Functional reach test evaluates dynamic balance by measuring the limits while the patient reaches forwards as far as possible. The test measure is centimeters. A higher score indicates better dynamic balance.
Measured: 15 minutes
One-leg stance test
One-leg stance test evaluates static balance of the participants. Participants would ask to maintain their static balance by standing one-lag stance. The test measure is second. A higher score indicated better static balance
Measured: 15 minutes
Romberg test
Romberg test is used to evaluate static balance. Participants would ask to maintain their balance with their feet together (touching each other). The test measure is second. Higher score indicated better balance.
Measured: 15 minutes
Berg balance scale
Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.
Measured: 15 minutes
Balance scale
Balance scale which is developed by Tinetti is used to evaluate functional balance. This test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the scale, the higher the risk of falling.
Measured: 15 minutes
Y balance test
Y balance test is used to evaluate dynamic balance. The Y balance test has the patient stand on one leg while reaching out in 3 different directions with the other lower extremity. They are anterior, posteromedial and posterolateral. The test measures in centimeters. The higher score indicates better balance
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Ozkal, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884088
- Sponsor's protocol ID
- GO 19/29
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensitivity of the Subjective Balance Tests
- ClinicalTrials.gov ID
- NCT03884088
- Acronym / sponsor ID
- GO 19/29
- Keywords
- Balance, Limits of Stability, Postural Sway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 21 Mar 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.
There is many subjective balance tests to evaluate static and dynamic balance. But, there is no sufficient information about which balance test is the most sensitive test to evaluate balance. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.
Detailed description
In the clinical setting, many balance tests are used for evaluating balance in individuals. These tests are utilized to assess both static and dynamic balance. However, sufficient research has not been conducted to decide which subjective balance test is more sensitive than the other tests. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Balance analysis | Experimental | Other: Limits of StabilityBalance will be assessed by Computerized Balance system and subjective balance tests. |
| Control Group: Balance analysis | Active comparator | Other: Limits of StabilityBalance will be assessed by Computerized Balance system and subjective balance tests. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years,
- To be a volunteer to participate
Key exclusion criteria (4 listed)
- orthopedic problems affecting gait and stance
- visual, auditory, orientational problems that could affect study results,
- Walking with assist device
- Having a neurological disorders
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 |
|---|---|---|
| Limits of StabilityAlso: Postural Sway test, Berg Balance Scale, Y Balance Test, Romberg Balance TestBalance analysis is assessment method to estimate fall of risk and deterioration of postural control. | Other | Control Group: Balance analysis, Experimental Group: Balance analysis |
Primary outcome
Limits of Stability
Time frame: 15 minutes
Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance
Postural Sway
Time frame: 15 minutes
Postural sway in centimeters by computerized balance system
7 secondary outcomes
Timed up and go test
Time frame: 15 minutes
Functional reach test
Time frame: 15 minutes
One-leg stance test
Time frame: 15 minutes
Romberg test
Time frame: 15 minutes
Berg balance scale
Time frame: 15 minutes
Balance scale
Time frame: 15 minutes
Y balance test
Time frame: 15 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 29 Mar 2022.
- 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?
A study testing Limits of Stability in people with Balance and Posture, run by Hacettepe 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 2 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: finished, as of the sponsor's last update on 29 Mar 2022. 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?
Limits of Stability (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 29 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.