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临床试验/NCT05910593
NCT05910593招募中不适用

Establishing the Validity and Reliability of a Dexterity Assessment Tool in DCM and Healthy Populations

Western University, Canada1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年6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
102
试验地点
1
主要终点
Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy

研究概览

简要总结

Every year, thousands of Canadians are diagnosed with degenerative cervical myelopathy (DCM), a form of non-traumatic injury caused by spinal cord compression in the neck. While DCM causes a range of symptoms, one of the most disabling is loss of hand dexterity. Surgical decompression is standard treatment for DCM, but reduced dexterity often remains.

The investigators have developed a portable, easy-to-use dexterity assessment tool for measuring hand dexterity. Hand function is often assessed using tools incapable of measuring subtle changes in function, limiting a clinician's ability to monitor progression of or recovery from a disease over time. The hope is that if subtle changes in function are identified early, leading to an early DCM diagnosis and treatment, this may prevent patients from experiencing a greater loss of hand function.

The goals of this study are to determine the relationship between dexterity and myelopathy severity, as well as to establish the validity and reliability of the dexterity tool. This will be done by assessing dexterity using the dexterity tool in DCM patients (to determine the relationship between disease severity and dexterity, and measure validity) and healthy participants (to establish reliability).

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy

时间窗: Dexterity will be assessed at one time point, when the participant is recruited

It is anticipated that disease severity will be defined based on the dexterity assessment tool

Correlation between the Dexterity Assessment Tool and the GRASSP-M tool (Graded Redefined Assessment of Strength, Sensation and Prehension-Myelopathy)

时间窗: Dexterity will be assessed with both tools at one time point, when the participant is recruited

Concurrent validity will be measured by correlating the Dexterity Assessment Tool with another validated tool, the GRASSP-M

Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure test-retest reliability

时间窗: Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.

Test-retest reliability will be assessed by measuring dexterity in healthy participants at two time points, one week apart. The data from the two time points will be correlated to determine reliability.

Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure inter-rater reliability

时间窗: Dexterity will be assessed in healthy participants at one time point, when the participant is recruited.

Inter-rater reliability will be assessed by measuring dexterity in healthy participants with two testers administering the tool one hour apart, and correlating the values from the two testers.

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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