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临床试验/NCT07327346
NCT07327346进行中(未招募)不适用

Test-Retest and Interrater Reliability and Validity of Postural Sway Parameters Measured With GYKO During the L Test in Individuals With Parkinson's Disease

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
25
试验地点
1
主要终点
Interrater Reliability of GYKO-Based Postural Sway Parameters

研究概览

简要总结

This study aims to investigate the interrater and test-retest reliability of GYKO-based postural sway measurements collected during the L-Test and Timed Up and Go (TUG) test in individuals with Parkinson's disease (Hoehn & Yahr stages 1-3). Two independent raters will perform GYKO-based assessments of the L-Test and TUG with a 20-minute interval. Participants will return one week later to repeat the same procedures for test-retest reliability. Concurrent validity will be examined using the Berg Balance Scale.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Other neurological, vestibular, or musculoskeletal disorders affecting balance
  • Deep brain stimulation (DBS) implant
  • Severe visual or auditory impairment

研究组 & 干预措施

Parkinson's disease group

Parkinson's disease patients with stage 1-3 hoehn yahr

干预措施: GYKO-Based Postural Sway Assessment (Other)

结局指标

主要结局

Interrater Reliability of GYKO-Based Postural Sway Parameters

时间窗: 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.

Test-Retest Reliability of GYKO-Based Postural Sway Parameters

时间窗: 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.

次要结局

  • L test and TUG Completion Time(1 week)
  • Validity of GYKO Postural Sway Parameters with Functional Mobility (TUG and L-Test)(Day 1)
  • Relationship Between Postural Sway and Balance Performance (Berg Balance Scale)(Day 1)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Büşra Akıncı

MSc

Hasan Kalyoncu University

研究点 (1)

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