- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03884088
Comparison of Subjective Balance Tests
March 14, 2022 updated by: Ozden Ozkal, Hacettepe University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06100
- Ozden Ozkal
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- at least 18 years,
- To be a volunteer to participate
Exclusion Criteria:
- orthopedic problems affecting gait and stance
- visual, auditory, orientational problems that could affect study results,
- Walking with assist device
- Having a neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: Balance analysis
Balance will be assessed by Computerized Balance system and subjective balance tests.
|
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
Other Names:
|
|
Active Comparator: Control Group: Balance analysis
Balance will be assessed by Computerized Balance system and subjective balance tests.
|
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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15 minutes
|
|
Postural Sway
Time Frame: 15 minutes
|
Postural sway in centimeters by computerized balance system
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed up and go test
Time Frame: 15 minutes
|
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
|
15 minutes
|
|
Functional reach test
Time Frame: 15 minutes
|
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.
|
15 minutes
|
|
One-leg stance test
Time Frame: 15 minutes
|
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
|
15 minutes
|
|
Romberg test
Time Frame: 15 minutes
|
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.
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15 minutes
|
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Berg balance scale
Time Frame: 15 minutes
|
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.
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15 minutes
|
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Balance scale
Time Frame: 15 minutes
|
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.
|
15 minutes
|
|
Y balance test
Time Frame: 15 minutes
|
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
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
March 16, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (Actual)
March 21, 2019
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GO 19/29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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