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临床试验/NCT07316985
NCT07316985已完成不适用

Time-Dynamic Study of Gait Variability in Children With Spastic Cerebral Palsy

LiNa Zhang1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Change in Step Time

研究概览

简要总结

This observational study is designed to investigate the time-dynamic characteristics of gait variability in children with spastic cerebral palsy (SCP). A total of 36 children with SCP and 36 age-, sex-, and BMI-matched typically developing children are recruited from the Children's Rehabilitation Center of the Affiliated Hospital of Binzhou Medical University. Using a portable gait analysis system (IDEEA, Minisun, USA) and a wireless surface electromyography system (Delsys, USA), participants perform a 3-minute continuous walking test at a self-selected comfortable speed. Key spatiotemporal gait parameters and electromyographic root mean square (RMS) values of the tibialis anterior and gastrocnemius muscles are assessed at predefined time points (10 seconds, 1 minute, 2 minutes, and 3 minutes). This study aims to examine temporal changes in gait variability and muscle activation during continuous walking in children with SCP, with the objective of identifying potential time points that may inform the optimization of walking-rest intervals in rehabilitation training.

详细描述

Spastic cerebral palsy (SCP) is the most common type of cerebral palsy and is characterized by increased muscle tone and impaired motor coordination. Gait variability reflects the dynamic stability and adaptive responses of the locomotor system during walking and is considered an important indicator for functional performance and rehabilitation planning. Understanding how gait parameters and muscle activation patterns evolve over time during continuous walking is essential for designing safe and effective rehabilitation programs for children with SCP. However, the temporal evolution of gait variability during sustained walking in this population remains insufficiently characterized.

This prospective observational case-control study enrolls a total of 72 participants, including 36 children diagnosed with SCP (Gross Motor Function Classification System levels I-II) and 36 typically developing children matched by age, sex, and body mass index. All participants perform a 3-minute continuous walking test at a self-selected comfortable speed on a flat surface.

Spatiotemporal gait parameters are recorded using a portable gait analysis system (IDEEA 3.01, Minisun, USA), while bilateral muscle activity of the tibialis anterior and gastrocnemius muscles is recorded using a Delsys wireless surface electromyography (EMG) system. Gait parameters include step time, cadence, stride length, stance phase, swing phase, gait cycle, and foot lift angle. Surface EMG signals are processed to obtain root mean square (RMS) values as indicators of muscle activation amplitude. Energy expenditure during walking is also estimated using the gait analysis system.

All gait, EMG, and energy expenditure measurements are obtained at predefined time points during the walking task, specifically at 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation. Data analysis is performed using SPSS version 26.0. Between-group comparisons and within-group time-series comparisons are conducted according to data distribution characteristics.

By systematically assessing spatiotemporal gait parameters, muscle activation patterns, and energy expenditure across multiple time points during continuous walking, this study aims to explore the temporal evolution of gait variability in children with spastic cerebral palsy. The results of this study are intended to provide objective data that may inform the development of appropriate walking-rest strategies and individualized rehabilitation programs to support walking safety and functional endurance in children with SCP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Children diagnosed with spastic cerebral palsy (SCP) according to the Chinese Guidelines for Cerebral Palsy Rehabilitation (2022).
  • Gross Motor Function Classification System (GMFCS) levels I-II.
  • Aged between 3 and 6 years.
  • Able to understand and follow verbal instructions.
  • Informed consent obtained from parents or legal guardians.

排除标准

  • Inability to cooperate with gait or EMG testing.
  • Presence of visual or hearing impairments.
  • History of severe epilepsy or other systemic diseases.
  • Received botulinum toxin or antispastic medication within the past 6 months.
  • Incomplete gait data or failure to complete the walking test.
  • For healthy controls: any neurological, orthopedic, or musculoskeletal disorder, or recent trauma affecting gait.

结局指标

主要结局

Change in Step Time

时间窗: 10 seconds, 1 minute, 2 minutes, 3 minutes

Step time was captured using the IDEEA 3.01 portable gait analysis system during a 3-minute continuous walking test. Step time values at 10 seconds, 1 minute, 2 minutes, and 3 minutes were compared to quantify temporal changes in gait variability in children with spastic cerebral palsy.

次要结局

  • Change in Stride Length (cm)(10 seconds, 1 minute, 2 minutes, 3 minutes)
  • Change in EMG RMS of Tibialis Anterior (µV)(10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation)
  • Change in EMG RMS of Gastrocnemius (µV)(3-minute continuous walking test)
  • Change in Energy Expenditure (kCal/min)(10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation)
  • Change in Cadence(10 seconds, 1 minute, 2 minutes, 3 minutes)
  • Change in Stance Phase (% gait cycle)(10 seconds, 1 minute, 2 minutes, 3 minutes)
  • Change in Swing Phase(10 seconds, 1 minute, 2 minutes, 3 minutes)

研究者

发起方
LiNa Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

LiNa Zhang

Principal Investigator

Yantai Affiliated Hospital of Binzhou Medical University

研究点 (1)

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