跳至主要内容
临床试验/NCT06994793
NCT06994793招募中不适用

Investigation of the Validity and Reliability of Gait and Jumping Parameters Measured With iSen Device in Healthy Adults

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Gait Speed

研究概览

简要总结

This study aims to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is a valuable tool for assessing general health, cognitive performance, quality of life, and mortality. It is commonly used by clinicians to assess functional limitations resulting from neurological or orthopedic conditions and to guide treatment plans. Traditional gait assessments primarily focus on walking speed, but additional parameters such as step length, step time, and gait symmetry are crucial for a comprehensive analysis.

The study will also assess vertical jump performance, which is a surrogate measure of explosive lower limb strength and is commonly used in sports performance and injury prediction. The iSen device, a wearable and affordable sensor, will be compared to the validated BTS G-Walk system to evaluate the accuracy and consistency of its measurements. Participants aged 18-35 with no history of musculoskeletal, neurological, or systemic conditions will be included.

The study will be conducted at Gazi University and Kırıkkale University, where participants will undergo assessments of gait and jump performance using both iSen and BTS G-Walk devices. A test-retest reliability protocol will be employed with a seven-day interval between measurements. The results will provide evidence on the suitability of the iSen device for reliable and valid gait and jump measurements in clinical settings

详细描述

This study seeks to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is an important tool in clinical settings as it provides valuable information about an individual's general health, cognitive performance, quality of life, and mortality risk. It is particularly useful for identifying functional limitations resulting from neurological or orthopedic conditions. Clinicians often rely on gait analysis to customize treatment plans, monitor individual progress, and assess the therapeutic benefits of interventions. Additionally, gait analysis can help identify underlying abnormalities and disorders that contribute to reduced functionality, thus aiding clinical decision-making.

Traditionally, clinical gait assessments focus on walking speed, typically measured using timed walking tests such as the 10-meter walk test or the 6-minute walk test. However, these assessments often fall short of providing a comprehensive evaluation, as they do not account for other important gait parameters such as step length, step time, or gait symmetry. Spatio-temporal gait parameters, such as walking speed, step time, step length, and step width, are essential for evaluating changes that may predict fall risk. Moreover, they are important for understanding motor function in a variety of populations.

Currently, laboratory-based equipment such as 3D motion capture systems and force plates are considered the gold standard for gait analysis due to their precision. However, these systems are often costly, require large spaces, and demand significant time for setup and analysis. As a result, they are not always accessible in clinical environments. In recent years, wearable accelerometers have gained popularity as an alternative for gait analysis. These devices offer several advantages, including low cost, portability, ease of use, and the ability to perform assessments in real-world settings, such as walking corridors. Notably, accelerometer-based gait analysis can be completed in a short period, typically within 10 minutes, making it an efficient option for clinical practice.

In addition to gait analysis, vertical jump performance is also a key parameter for assessing lower extremity strength and explosive power. Jumping performance can provide insights into athletic ability, physical fitness, and injury risk. Vertical jump height, in particular, is widely used by physiotherapists, trainers, and health professionals to assess strength, neuromuscular fatigue, and explosive power. Several methods are used to measure jump height, including contact mats, force plates, and accelerometers. However, force plates, considered the gold standard, are not portable and require specialized expertise to operate. As a result, wearable sensors like the iSen device have emerged as a practical and cost-effective alternative for jump performance analysis.

The iSen device is a wearable, wireless sensor that offers advantages over traditional laboratory-based equipment due to its portability, affordability, and ease of use. However, there is limited evidence regarding the validity and reliability of the iSen device in measuring gait and jump parameters. This study aims to fill this gap by comparing the iSen device with the validated BTS G-Walk system, which has demonstrated reliability and validity in gait and jump assessments. By evaluating the performance of the iSen device in measuring spatio-temporal gait parameters and jump performance, the study seeks to provide evidence for its potential clinical use.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 35 years. Voluntarily agree to participate in the study. No history of surgery in the lower extremities.

排除标准

  • Any musculoskeletal, neurological, or systemic pathology that could affect gait or jumping performance.
  • Inability to comply with study procedures.

结局指标

主要结局

Gait Speed

时间窗: Baseline and 1 week later

Gait speed (m/s) will be measured using the iSen system at baseline and one week later. At baseline, measurements will also be collected using the BTS G-Walk system for comparison to determine the validity of the iSen device in healthy adults.

Cadence

时间窗: Baseline and 1 week later

Cadence (steps/min) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.

Step Length

时间窗: Baseline and 1 week later

Step length (m) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.

Stance Phase Duration

时间窗: Baseline and 1 week later

Stance phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.

Step Time

时间窗: Baseline and 1 week later

Step time (s) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for comparison.

Swing Phase Duration

时间窗: Baseline and 1 week later

Swing phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.

Double Support Phase Duration

时间窗: Baseline and 1 week later

Double support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.

Single Support Phase Duration

时间窗: Baseline and 1 week later

Single support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation

Pelvic Angles

时间窗: Baseline and 1 week later

Pelvic angles (degrees) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation

Jump Height

时间窗: Baseline and 1 week later

Jump height (cm) will be measured during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only the iSen system one week later. The highest value from three jumps will be recorded.

Take-off Force

时间窗: Baseline and 1 week later

Take-off force (kN) during a countermovement jump will be measured with the iSen and BTS G-Walk systems at baseline, and with iSen only one week later. The trial with the highest value will be analyzed.

Maximum Concentric Power

时间窗: Baseline and 1 week later

Maximum concentric power (kN) during a countermovement jump will be measured using both iSen and BTS G-Walk systems at baseline, and only iSen at one week. The value from the best trial will be used for analysis.

Landing Impact Force

时间窗: Baseline and 1 week later

Landing impact force (kN) will be assessed using both the iSen and BTS G-Walk systems at baseline, and the iSen system only at one-week follow-up.

Maximum Jump Velocity

时间窗: Baseline and 1 week later

Maximum vertical velocity (m/s) during a countermovement jump will be measured using the iSen and BTS G-Walk systems at baseline, and only iSen one week later. The maximum value from three trials will be recorded.

Take-off Velocity

时间窗: Baseline and 1 week later

Take-off velocity (m/s) will be assessed during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only iSen at 1-week follow-up. The highest value will be selected.

次要结局

未报告次要终点

研究者

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

Saniye Aydoğan Arslan

Associate Professor

Kırıkkale University

研究点 (1)

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