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临床试验/NCT04006418
NCT04006418招募中不适用

A Registered Cohort Study on Spastic Paraplegia

Wan-Jin Chen1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Spastic Paraplegia Rating Scale (SPRS)

研究概览

简要总结

The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement..

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with the clinical diagnosis of spastic paraplegia
  • Clinical diagnosis of patients with spastic paraplegia
  • Unrelated healthy controls

排除标准

  • Decline to participate.
  • There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.

结局指标

主要结局

Spastic Paraplegia Rating Scale (SPRS)

时间窗: 6 months

Disease severity will be assessed by application of the Spastic Paraplegia Rating Scale (SPRS), a clinical rating scale measuring disease severity in Hereditary Spastic Paraplegia (Schule et al. Neurology 2006). The SPRS contains 13 items, each ranging from 0 to 4 points. The total score is calculated as the sum of all items, yielding a range for the total score between 0 and 52. Hereby, higher SPRS total scores indicate more severe disease.

次要结局

未报告次要终点

研究者

发起方
Wan-Jin Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wan-Jin Chen

The Vice-Director for the Department of Neurology

First Affiliated Hospital of Fujian Medical University

研究点 (1)

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