- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327346
GYKO-Based L-Test Reliability in Parkinson's Disease
Test-Retest and Interrater Reliability and Validity of Postural Sway Parameters Measured With GYKO During the L Test in Individuals With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to investigate the test-retest and interrater reliability, as well as the concurrent validity, of GYKO-based postural sway measurements obtained during the L-Test and the Timed Up and Go (TUG) test in individuals with Parkinson's disease. Participants diagnosed with idiopathic Parkinson's disease (Hoehn & Yahr stages 1-3) will be evaluated using the GYKO inertial measurement unit, which provides quantitative postural sway parameters including ellipse area, mean length, mediolateral and anteroposterior mean length, mediolateral and anteroposterior mean distance, and velocity.
Two independent raters will perform GYKO-based assessments of the L-Test and TUG on the same day, with a 20-minute interval between raters, to determine interrater reliability. Participants will return one week later to repeat the same procedures, allowing assessment of test-retest reliability.
To examine concurrent validity, participants' functional balance will also be assessed using the Berg Balance Scale, and correlations between GYKO variables and clinical mobility tests (L-Test and TUG) will be analyzed.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Şahinbey
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Gaziantep, Şahinbey, Turkey (Türkiye), 27000
- Hasan Kalyoncu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease
- Hoehn & Yahr stage 1-3
- Ability to walk independently with or without an assistive device
- Ability to follow verbal instructions
- Age 50-85
Exclusion Criteria:
- Other neurological, vestibular, or musculoskeletal disorders affecting balance
- Deep brain stimulation (DBS) implant
- Severe visual or auditory impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parkinson's disease group
Parkinson's disease patients with stage 1-3 hoehn yahr
|
This procedure involves obtaining postural sway parameters using the GYKO inertial measurement device during the Time Up and Go (TUG) test and L-Test. No therapeutic intervention is applied. Time Up and Go Test: Timed Up and Go (TUG) is a standardized functional mobility test used to assess dynamic balance and gait performance. Participants are instructed to stand up from a standard-height chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time to complete the task (in seconds) is recorded. Higher times indicate reduced mobility. L Test: Time (in seconds) to complete the L-Test of Functional Mobility. The test requires participants to stand up from a chair, walk 3 m, execute a 90° turn, walk another 7 m, perform a 180° turn, and return along the same path (total walking distance ≈ 20 m). The task ends when the participant sits back down. The total time to complete the task (in seconds) is recorded. Higher times indicate reduced mobility. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interrater Reliability of GYKO-Based Postural Sway Parameters
Time Frame: Day 1
|
Interrater reliability of postural sway will be evaluated using a composite set of parameters derived from GYKO inertial sensor data collected during the Timed Up and Go (TUG) and L-Test procedures. Measurements will be obtained independently by two raters on the same day. The composite postural sway outcome includes ellipsoid area, displacement-related parameters in the mediolateral and anteroposterior directions, and velocity-related parameters. Although individual variables are expressed in different units, all parameters collectively represent a single postural control construct. Interrater reliability will be assessed using the intraclass correlation coefficient (ICC 2,1) with 95% confidence intervals. |
Day 1
|
|
Test-Retest Reliability of GYKO-Based Postural Sway Parameters
Time Frame: 1 week
|
Test-retest reliability of postural sway will be assessed using a composite set of parameters derived from GYKO inertial sensor data collected during the Timed Up and Go (TUG) and L-Test procedures. Participants will be re-evaluated after a 1-week interval. The composite postural sway outcome includes ellipsoid area, mediolateral and anteroposterior displacement parameters, and velocity-related parameters, representing a single postural control construct. Test-retest reliability will be analyzed using the intraclass correlation coefficient (ICC 3,1) with 95% confidence intervals. Paired t-tests will be used to examine differences between test and retest measurements. |
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity of GYKO Postural Sway Parameters with Functional Mobility (TUG and L-Test)
Time Frame: Day 1
|
Concurrent validity will be examined by analyzing the relationship between the composite GYKO-based postural sway parameters obtained during the Timed Up and Go (TUG) and L-Test procedures and functional mobility performance. Pearson correlation coefficients will be used to assess the associations between postural sway composite outcomes and TUG and L-Test completion times. |
Day 1
|
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Relationship Between Postural Sway and Balance Performance (Berg Balance Scale)
Time Frame: Day 1
|
Balance performance will be assessed using the Berg Balance Scale at baseline.
The relationship between Berg Balance Scale scores and the composite GYKO-based postural sway parameters obtained during the Timed Up and Go (TUG) and L-Test procedures will be analyzed using Pearson correlation coefficients.
|
Day 1
|
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L test and TUG Completion Time
Time Frame: 1 week
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test and the L-Test. The TUG requires participants to stand up from a chair, walk 3 meters, turn, return, and sit down. The L-Test is a modified version of the TUG and consists of standing up from a chair, walking 3 meters, performing a 90° turn, walking an additional 7 meters, performing a 180° turn, and returning along the same path (total walking distance approximately 20 meters). The time required to complete each test will be recorded in seconds. |
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Büşra Akıncı, MSc, Hasan Kalyonuc University
- Principal Investigator: Saadet Nur Çörekçioğlu, P.T., Hasan Kalyoncu University
- Study Director: Günseli Usgu, Assoc. Prof., Hasan Kalyoncu University
Publications and helpful links
General Publications
- Haas B, Clarke E, Elver L, Gowman E, Mortimer E, Byrd E. The reliability and validity of the L-test in people with Parkinson's disease. Physiotherapy. 2019 Mar;105(1):84-89. doi: 10.1016/j.physio.2017.11.218. Epub 2017 Dec 5.
- Zampieri C, Salarian A, Carlson-Kuhta P, Aminian K, Nutt JG, Horak FB. The instrumented timed up and go test: potential outcome measure for disease modifying therapies in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Feb;81(2):171-6. doi: 10.1136/jnnp.2009.173740. Epub 2009 Sep 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKU/PH/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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