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临床试验/NCT05374174
NCT05374174进行中(未招募)不适用

Validation of a Spasticity Measurement Tool

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月28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)
入组人数
40
试验地点
1
主要终点
Catch angle

研究概览

简要总结

The objective of this project is to investigate the validity of a handheld spasticity measurement tool against standard clinical measurements of spasticity. We propose the testing apparatus will accurately provide an equivalent clinical measure of spasticity while also providing a more precise estimation of spastic response in persons with stroke.

详细描述

An ongoing conversation amongst clinicians exists on how to properly define, measure, and manage spasticity. The standard measurement tools are the Modified Ashworth Scale (MAS) and the Tardieu scale, although both of these lack reliability and specificity, causing variability between clinicians and a lack of accurate spasticity measurement. In addition, some have concerns about whether the MAS measures true spasticity at all. Due to this lack of trust in these scales, clinicians often use them as a communication tool to identify the presence of spasticity, rather than as reliable quantifiable outcome measurements.

The MAS and Tardieu function mainly on the principal of catch, a limb is moved slowly by a clinician through the available range of motion, and then quickly. Hyperactive muscles are sensitive to velocity dependent stretch and will activate a reflex if quickly perturbed. In both the MAS and Tardieu, the catch location is noted and translated into a score. In MAS the catch location is only noted in three distinct ranges; with the Tardieu Scale the catch angle is remembered by the clinician and recorded after the movement with a standard goniometer.

Here we will test a new handheld spasticity measurement tool MITSS (Modified Intelligent Tardieu Scale for Spasticity), which is essentially a 3-DOF digital goniometer, to quantify the catch angle as well as general forces at the joint.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age 18-75
  • Able to provide informed consent
  • History of unilateral stroke

排除标准

  • Orthopedic injuries or surgeries that would impact arm function

结局指标

主要结局

Catch angle

时间窗: Baseline

Elbow angle in which there is a marked increase in tone while rotating quickly. This is measured while the clinician is wearing the MITSS and rotating participant's elbow slowly and quickly through the range of motion. This measure will be taken at 2 minute increments over 30 minutes

次要结局

  • Modified ashworth score(Baseline)
  • Tardieu Spasticity Score(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zev Rymer

Director Single Motor Unit Laboratory

Shirley Ryan AbilityLab

研究点 (1)

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