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临床试验/NCT02557711
NCT02557711Unknown不适用

The Correlation Between Clinical Examination and Ultrasound Elastography Acoustic Radiation Force Impulse Findings in Hemiplegic Patients With Elbow Flexor Spasticity After Stroke

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)

研究概览

简要总结

The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/ ARFI imaging in spasticity evaluation of stroke patients.

详细描述

Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS) are the most commonly used tools for spasticity assessment. But these clinic methods cannot reveal the architecture and stiffness of muscles. In recent years, ultrasound elastography and acoustic radiation force impulse (ARFI) are used in musculoskeletal disorders, including spasticity. There are no studies about the correlation between spasticity and ultrasound elastography /ARFI imaging in stroke patients. The investigators will enroll 50 stroke patients with hemiplegia and biceps brachii muscle spasticity. One physical therapist will measure MAS and MTS for spasticity of biceps brachii muscle. Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation. The evaluations of B-mode ultrasound, elastography and ARFI included Heckmatt scale, biceps brachii ratio, strain ratio, dynamic sonoelastography score, color intensity, and shear wave velocity. After performing all assessments, the investigators will analyze the correlation between the clinic tools and elastography/ ARFI imaging and evaluate the reliability of elastography/ ARFI imaging in spasticity evaluation.

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

性别
All
接受健康志愿者

入选标准

  • stroke patients with hemiplegia and biceps brachii muscle spasticity.

排除标准

  • elbow joint contracture deformity
  • combined other neuromuscular system disease
  • affected upper extremity has local infection
  • patient who can't follow instruction, who is restlessness and whose elbow can't meet the positioning criteria

结局指标

主要结局

Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)

时间窗: patients will be evaluated within 1 month after basic history taking and consent signing

次要结局

  • Dynamic Sonoelastography Score(DS score)(patients will be evaluated within 1 month after finishing history taking and consent signing)
  • shear wave velocity within region of interest between biceps brachii and brachialis(patients will be evaluated within 1 month after finishing history taking and consent signing)
  • Heckmatt scale(patients will be evaluated within 1 month after finishing history taking and consent signing)
  • strain ratio(patients will be evaluated within 1 month after finishing history taking and consent signing)
  • the thickness of biceps brachii(patients will be evaluated within 1 month after basic history taking and signing consent)
  • The mean values of the intensity of red, green, and blue on histogram of bicep brachii(patients will be evaluated within 1 month after finishing history taking and consent signing)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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