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临床试验/NCT07730086
NCT07730086招募中不适用

Concurrent Validity and Test-Retest Reliability of Smartphone-Embedded Accelerometry for Spatiotemporal Gait Analysis in Children With Unilateral Spastic Cerebral Palsy

Deraya University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
35
试验地点
1
主要终点
Walking Velocity Measured by Smartphone Accelerometry

研究概览

简要总结

This observational study will evaluate whether a smartphone's built-in accelerometer can provide accurate and repeatable measurements of walking in children with unilateral spastic cerebral palsy.

Thirty-five children aged 6 to 12 years will complete two walking trials along a 10-meter indoor walkway at their usual comfortable speed. During each trial, a smartphone will be secured over the lower back at the L4-L5 level to record body acceleration using the Phyphox application. At the same time, a video camera will record the child's walking for analysis using Kinovea software.

Measurements obtained from the smartphone will be compared with measurements obtained from video analysis. The study will assess walking velocity, cadence, stride timing, and gait asymmetry. The two repeated walking trials will also be used to determine whether the smartphone measurements are consistent when the test is repeated during the same session.

The study does not involve any treatment or change to the child's usual medical or physical therapy care. The purpose is to determine whether smartphone-based gait assessment may be a practical, low-cost method for evaluating walking in children with unilateral spastic cerebral palsy.

详细描述

Children with unilateral spastic cerebral palsy may have differences in walking speed, step timing, cadence, and symmetry between the affected and unaffected lower limbs. Instrumented gait laboratories can provide detailed gait measurements, but they may be expensive, time-consuming, or unavailable in many clinical settings. Smartphones contain built-in motion sensors that may offer a simpler and more accessible method of measuring gait.

This methodological validation study will examine the concurrent validity and intra-session test-retest reliability of smartphone-embedded linear accelerometry for the assessment of spatiotemporal gait parameters in children with unilateral spastic cerebral palsy.

A convenience sample of 35 children will be recruited from the Deraya University outpatient clinic. Eligible participants will be 6 to 12 years of age, have a clinical diagnosis of unilateral spastic cerebral palsy, and be classified as Gross Motor Function Classification System level I or II.

Each participant will attend one assessment session. A Samsung Galaxy A7 smartphone will be secured horizontally over the lower back at the L4-L5 vertebral level using an adjustable waist belt. This location is intended to approximate the body's center of mass. The smartphone's internal linear accelerometer will record movement data using the Phyphox application.

Participants will walk at a comfortable, self-selected speed along a flat, unobstructed 10-meter indoor walkway. At the same time, a high-definition video camera mounted on a stable tripod will record the walking trial from a perpendicular distance of approximately 3 meters. The video recordings will be analyzed frame by frame using Kinovea software and will serve as the reference method.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of unilateral spastic cerebral palsy.
  • Chronological age ranging from 6 to 12 years.
  • Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
  • Ability to comprehend and execute simple verbal instructions during clinical evaluation.

排除标准

  • History of lower extremity corrective orthopedic surgery or joint casting within the preceding 12 months.
  • Botulinum Toxin Type A injections administered to the lower limbs within the past 6 months.
  • Fixed structural bony deformities or rigid joint contractures in the lower extremities.
  • Severe, uncorrected visual or auditory deficits that threaten safety or test execution

结局指标

主要结局

Walking Velocity Measured by Smartphone Accelerometry

时间窗: Baseline

Walking velocity, expressed in meters per second, will be calculated by dividing the 10-meter walking distance by the time required to complete the walkway. Velocity derived from smartphone linear accelerometry using the Phyphox application will be compared with velocity obtained from frame-by-frame 2-dimensional video analysis using Kinovea software.

Cadence Measured by Smartphone Accelerometry

时间窗: Baseline

Cadence, expressed as steps per minute, will be calculated from acceleration peak intervals recorded by the smartphone using the Phyphox application. Smartphone-derived cadence will be compared with cadence determined by visual frame-by-frame analysis of the simultaneous Kinovea video recording.

Gait Asymmetry Index

时间窗: Baseline

The Gait Asymmetry Index will be calculated using temporal gait data from the affected and unaffected lower limbs. The index will quantify the degree of asymmetry between the two sides. Smartphone-derived asymmetry values will be compared with values obtained from the simultaneous Kinovea video analysis. Higher values indicate greater gait asymmetry.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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