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临床试验/NCT03814460
NCT03814460已完成不适用

Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity

University of Seville2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Muscle Tone Assessment, using the modified Tardieu Scale

研究概览

简要总结

Spasticity is defined as a state of increased muscle tone, which evokes an increased resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity depends, among other things, on the stretching velocity performed to the muscle. However, most of the tools used in the clinical setting to assess spasticity do not take into account the relationship between increased muscle tone and speed of stretching. Instead of that, muscle tone is usually assessed in a relaxed position of the muscle.

Likewise, to date, despite the functional disabilities related to the presence of chronic pain after a stroke, no previous study has correlated muscle tone and pressure pain sensitivity within this population

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be older than 18 years
  • Clinical diagnosis of stroke, confirmed using a MRI.
  • No previous history of other strokes.
  • Increases muscle tone in upper and lower extremities (punctuation equal to or superior to 1 in the Tardieu Scale, Ashworth Scale)
  • Ability to understand the study goals, follow simple instructions and provide informed consent.
  • Score equal to or superior to 24 in the Minimental State Examination.

排除标准

  • Any other confirmed neurological disorder that may influence muscle tone (multiple sclerosis, Parkinson, muscle dystrophies...)
  • A chronic musculoskeletal disorder in the upper or lower limb.
  • Previous history of surgery in the upper or lower extremities.
  • Changes in the medication intake that may affect muscle tone assessments in the 48 hours before data collection.
  • Having received botulin toxin in gastrocnemius or biceps brachii muscles in the 30 days before data collection.
  • A concomitant acute infection during data collection.
  • A previous epileptic crisis in the week before the study or during the study.

结局指标

主要结局

Muscle Tone Assessment, using the modified Tardieu Scale

时间窗: One time assessment

The modified Tardieu Scale is the most common tool used in the clinical setting to evaluate the muscle tone. The muscle response to a slow and fast stretching will be performed. During the fast stretching, the joint angle in which the muscle responds with difficulty will be collected using an electrogoniometer.

Pressure Pain Threshold, assessed by Manual Pressure Algometry

时间窗: One time assessment

A handheld electronic pressure algometer with a 1-cm2 contact probe will be used. Pressure pain thresholds (PPTs), as the minimum necessary pressure force to evoke pain, will be assessed bilaterally over biceps brachii and the gastrocnemius muscles (medial and lateral). Assessments will be made using a topographical mapping covering myotendinous and muscle belly sites in the above mentioned muscles. A 30-second break will be used between assessments to prevent bruising, and an average of the two measures over each site will be calculated for the statistical analysis. Pressure algometry is reliable in healthy individuals, and in stroke patients

次要结局

  • Muscle State of Tension (Muscle Tone), assessed by a myotonometer(One time assessment)
  • Muscle Thickness(One time assessment)
  • Muscle Stiffness, assessed by a myotonometer(One time assessment)

研究者

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

Alberto Marcos Heredia-Rizo

Assistant Professor. Physiotherapy Department

University of Seville

研究点 (2)

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