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临床试验/NCT05913934
NCT05913934进行中(未招募)不适用

Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins

Dr.Joller BioMedical Consulting1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
24
试验地点
1
主要终点
Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value

研究概览

简要总结

Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis.

GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison.

Nonparametric statistics are applied to verify aberrations.

详细描述

Control gait analysis in clubfoot children and comparison with their healthy twins

Clubfeet are the most common birth defect with about 80 cases in Switzerland per year. There are two important therapies: Ponseti and manual-dynamic physiotherapy.

Ursula Issler-Wüthrich, physiotherapist, since twenty years treats exclusively clubfeet and comorbidities with clubfeet like arthrogryposis and myelomeningocele. Until today she corrected more than 400 feet with manual-dynamic physiotherapy.

Among her patients there are 11 twin pairs. In the scientific literature it is stated that in unilateral clubfoot, the other foot cannot be considered normal.With the two gait analysis systems meant for controlling the therapy results, the walking pattern of the healthy twin was compared with the pattern of the affected twin sibling.

The basis of the study is a walk over 25 meters with the GaitUp sensors (11 g) resulting in 22 quantitative digital parameters and tests on the pedobarographic plate footscan V9 leading to 10 parameters.

研究设计

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

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Twins with clubfeet

排除标准

  • All other clubfeet

结局指标

主要结局

Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value

时间窗: 2 years

The gait analyses parameters are statistically compared between the healhy siblings and the clubfoot twins. The p-values descibe the disparity among the groups. p-values below 0.05 point to a statistical difference and are a clue to insufficient therapy.

Differences in gait analyses of treated clubfeet and their healthy twin siblings:Effect size

时间窗: 2 years

The effect size is a measure for the interpretation of differences. It represents the shift between the standard curves of the two populations. Effect sizes of more than ±0.5 suggests a serious discrepancy.

次要结局

未报告次要终点

研究者

发起方
Dr.Joller BioMedical Consulting
申办方类型
Other
责任方
Sponsor

研究点 (1)

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