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临床试验/NCT06448065
NCT06448065Enrolling By Invitation不适用

A Reliability Study of Gait Classification in Children With Cerebral Palsy

Region Stockholm1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Concurrent validity

研究概览

简要总结

The goal of this observational study is to assess whether gait classification patterns can be reliably obtained from video recordings in comparison with three-dimensional kinematic data.

The main questions it aims to answer are:

Are gait classifications from video recordings reliable between raters? Are gait classifications from video recordings valid in comparison with three-dimensional kinematic data?

Gait analysis data from participants who visited the gait lab in the Karolinska Hospital will be used for this purpose.

详细描述

Current retrospective observational study aims to assess the reliability and validity of gait pattern classification systems in ambulatory children with CP. Gait classification is often performed using kinematic gait data obtained via a three dimensional (3D) data captured in a specialized gait lab using infra-red cameras. However, not all hospitals and clinical centers have access to such a specialized gait lab, and therefore often use video recordings as an alternative for gait classification. It is currently not known whether such a classification based on solely video recordings is equally reliable in comparison with kinematic gait data. For this purpose, current study aims to assess the reliability and validity of video recordings to classify children with CP according to predefined gait classifications. Sagittal plane video recordings during barefoot walking in children with CP will be used to classify the study participants into seven different gait classification patterns. For reliability, inter-rater reliability between raters scoring the video recordings will be assessed. To evaluate whether video recordings could serve as a valid alternative for kinematic gait data, the agreement between the classifications from the video recordings and the kinematic data additionally will be assessed.

研究设计

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

入排标准

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

入选标准

  • Main diagnosis of spastic cerebral palsy
  • Age 3 to 18 at the time of gait analysis
  • Availability of barefoot walking data collected at the Karolinska Hospital gait lab
  • Written informed consent of both parents to use the clinically collected data as research data

排除标准

  • Main diagnosis of dyskinetic or ataxic cerebral palsy
  • No barefoot walking trials available
  • No kinematic data available
  • BTX-A injections 6 months prior to gait analysis
  • Orthopaedic surgery one year prior to gait analysis

结局指标

主要结局

Concurrent validity

时间窗: approximately 12 months

Assess concurrent validity between outcome classifications from video recordings and from three-dimensional gait kinematics children with cerebral palsy

Inter-rater reliability

时间窗: approximately 12 months

Assess inter-rater reliability between multiple raters assessing video recordings of gait in children with cerebral palsy

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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