Comparison of Subjective Balance Tests

• ClinicalTrials.gov Identifier: NCT03884088
• Recruitment Status: Recruiting
• First Posted: March 21, 2019
• Last Update Posted: February 11, 2020
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Ozden Ozkal, Hacettepe University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Balance; Posture	Other: Limits of Stability	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Comparison of Sensitivity of the Subjective Balance Tests
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: April 1, 2020
• Estimated Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Group: Balance analysis; Balance will be assessed by Computerized Balance system and subjective balance tests.	Other: Limits of Stability; Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.; Other Names: Postural Sway test; Berg Balance Scale; Y Balance Test; Romberg Balance Test; One-Leg Stance Test; Tinetti Balance Test; Timed up an go test; Functional Reach Test

Outcome Measures

Primary Outcome Measures :

1. 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
2. Postural Sway [ Time Frame: 15 minutes ]
   Postural sway in centimeters by computerized balance system

Secondary Outcome Measures :

1. 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
2. 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.
3. 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
4. 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.
5. 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.
6. 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.
7. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Turkey

Ozden Ozkal; Recruiting

Ankara, Turkey, 06100

Contact: Ozden Ozkal ozdenozkal@gmail.com

Sponsors and Collaborators

Hacettepe University

More Information

• Responsible Party: Ozden Ozkal, Principal Investigator, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03884088
• Other Study ID Numbers: GO 19/29
• First Posted: March 21, 2019
• Last Update Posted: February 11, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ozden Ozkal, Hacettepe University:

Balance; Limits of Stability; Postural Sway