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临床试验/NCT06193642
NCT06193642已完成不适用

Increasing Knowledge on Osteogenesis Imperfecta by Collecting and Integrating Epidemiological Data, Genetic Information, and Functional Performance From Movement Analysis

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年1月20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
33
试验地点
2
主要终点
Gait-Analysis

研究概览

简要总结

interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta

详细描述

Subjects diagnosed with Osteogenesis Imperfecta will be undergoing, after collection of informed consent, to a series of assessments using sensor imaging and Gait-Analysis and collection of specific parameters

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Osteogenesis Imperfecta (clinical diagnosis) able to perform the gait-analysis movement data acquisition session, in the most complete instrumental configuration, i.e., with kinematics, dynamics and electromyography; it will naturally be evaluated which motor tasks are safely executable and which are not.
  • All patients of both sexes will be included
  • Patients in the age range: 8-60 will be included

排除标准

  • Subjects who do not fit the inclusion criteria

研究组 & 干预措施

experimental

Experimental

Through gait analysis acquisition sessions in the most comprehensive configuration possible on a test group of patients, the aim is to identify measures to be collected at regime for simplified evaluation including patient acceptability.

Patients will be asked to complete quality of life questionnaires.

干预措施: experimental (Other)

结局指标

主要结局

Gait-Analysis

时间窗: through study completion, an average of 1 year

Parameter detection via specific sensors including Inertial Motion Units

次要结局

  • quality of life questionnaires(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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