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临床试验/NCT01705834
NCT01705834撤回不适用

The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis

Western Health and Social Care Trust1 个研究点 分布在 1 个国家开始时间: 2012年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Correlation between maximum velocity of movement and the patient reported severity of joint stiffness

研究概览

简要总结

This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.

详细描述

We will use a dataglove to record joint movements in a small number of patients with rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements measured by the glove will correlate with symptoms of joint stiffness in the hands of patients with rheumatoid arthritis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients aged 18 to 80
  • Diagnosis of Rheumatoid arthritis
  • Patients who have significant pain and stiffness in their hands
  • Correct hand size to achieve a good fit to the dataglove
  • Able to follow instructions for use of dataglove/computer

排除标准

  • Severe pain in the right hand
  • Severe swelling in the right hand (rated as such by the investigator)
  • Severe permanent deformity or loss of function in the fingers of the right hand
  • Broken or infected skin in the right hand
  • Known to have been MRSA positive currently or in the past
  • Unable to don and doff the disposable lining glove and the dataglove without significant discomfort
  • Poor fit for the disposable lining glove or the dataglove
  • History of latex allergy

结局指标

主要结局

Correlation between maximum velocity of movement and the patient reported severity of joint stiffness

时间窗: Maximum of 7 days

A significant inverse correlation is expected to be found between the patient's assessment of the severity and/or duration of stiffness and the maximum velocity of movement at the main finger joints.

次要结局

  • Number of patients withdrawing from the study(Over the period of testing of the dataglove - 7 day timeframe)

研究者

发起方
Western Health and Social Care Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Philip Gardiner

Consultant Rheumatologist

Western Health and Social Care Trust

研究点 (1)

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