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临床试验/NCT05571501
NCT05571501已完成不适用

Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway

Great Ormond Street Hospital for Children NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 702 人开始时间: 2012年5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
已完成
入组人数
702
试验地点
1
主要终点
Gait data recorded via GAITRite software

研究概览

简要总结

Walking measurement in children is important but there are challenges associated with obtaining reliable repeatable data in a clinical setting that is meaningful and easy to interpret. This study set out to develop a new way to collect, record, and interpret walking data that is suitable for the clinical environment. Developmental percentile charts were selected as they are widely recognised and easily interpreted.

详细描述

The primary output of the main cohort of typically developing children is the developmental percentile charts.

These will be then used to present the clinical longitudinal data against a normal backdrop of developmental changes in children.

This has multiple clinical applications in many of the children assessed by physiotherapy at GOSH and more widely Nationally and internationally

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

All children recruited underwent the GAITRite assessment

入排标准

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

入选标准

  • •Able to walk 100m

排除标准

  • •recent fracture or musculoskeletal injury which would affect gait

研究组 & 干预措施

Typically developing children

Active Comparator

500 children aged 1-18 male and female will be recruited from local schools, after school clubs and playgroups.

Each child will complete a screening form following appropriate information and consent process. Each child will then complete the walking assessment which takes 15 minutes in total

干预措施: Gait assessment using the GAITRIte walkway (Device)

Clinical groups

Active Comparator

Children will be recruited through their patient journey. Families who consent to participation will complete the screening form and the GAITRite walking assessment as part of their pre-planned clinical followup in outpatient clinics.

One group of children will be assessed at one time point, whilst a second group of children with progressive orthopaedic conditions or treatment will be assessed at intervals to give longitudinal data

干预措施: Gait assessment using the GAITRIte walkway (Device)

结局指标

主要结局

Gait data recorded via GAITRite software

时间窗: For the duration of the study measured once for typically developing and at multiple clinic visits over 24 months for clinical groups

Continuous numeric data summarising walking performance and characteristics

次要结局

  • demographic and clinical outcome data(30 to 60 mins to collect relevant data at a single time point, with an update to include additional admissions over 24months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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