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临床试验/NCT04550793
NCT04550793Unknown不适用

Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Shear Wave Ultrasound Elastography

研究概览

简要总结

Spasticity of stroke patient, a very common complication in clinical practice, affects performance of hand function and gait pattern. It also interferes with quality of life of patients severely. Currently first line clinical approach to spasticity consist of physical therapy and pharmacological management. However, there are still some refractory cases that needed local intervention such as Botox injection.

So far, we only can use subjective methods to measure muscle tension, such as modified Ashworth scale and Tone Assessment Scale. In our previous study, we found that ultrasound shear wave image could correlate with muscle stiffness caused by poststroke spasticity. With this new method, we aim to establish a more objective method in measuring abnormal poststroke muscle tension before and after treatments and further monitor therapeutic effect. We also include several assessment scales to evaluate the correlation between measured muscle spasm and activity of daily living.

We hypothesize that the rheological changes in muscles muscle spasm after Botox injection can be detected by ultrasound shear wave image. Therapeutic effect can also be seen in its effect on daily functions.

In this project, we will use shear wave imaging of ultrasound to investigate the elasticity (and hardness) of the biceps brachii and brachialis muscle in stroke patients with unilateral hemiplegia before and after Botox injection. The findings of this project will provide the objective evaluation of muscle spasticity and its correlation with functional status, which will provide new points of view toward treatment of spasticity.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • [Intervention group]
  • Stroke patients with unilateral involvement
  • Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale
  • Patient required botulinum toxin injection at affected upper limb muscle per primary care physician.
  • [Control group]
  • Stroke patients with unilateral involvement
  • Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale

排除标准

  • Patients ever diagnosed with cerebral diseases other than stroke, such as traumatic brain injury, encephalitis and brain tumor
  • Patients failed to cooperated due to cognition, consciousness or speech problem
  • Patients with illness that could affect muscle stiffness, such as spinal cord injury and Parkinson's disease
  • Patients with upper limb contracture
  • Patients receiving botulinum toxin injection or shock wave therapy over upper extremities during past three months

研究组 & 干预措施

Intervention

The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials.

干预措施: Botulinum toxin injection (Drug)

结局指标

主要结局

Shear Wave Ultrasound Elastography

时间窗: During each follow up visit within 12 weeks time frame

Shear wave ultrasound elastography measurement of spastic upper limb muscles, including biceps brachii and brachialis

次要结局

  • Barthel Index (Wade's version)(During each follow up visit within 12 weeks time frame)
  • Revised Nottingham Extended Activities of Daily Livings Scale(During each follow up visit within 12 weeks time frame)
  • Tone Assessment Scale (TAS)(During each follow up visit within 12 weeks time frame)
  • Postural Assessment Scale for Stroke Patients (PASS), brief version(During each follow up visit within 12 weeks time frame)
  • Stroke Rehabilitation Assessment of Movement (STREAM), brief version(During each follow up visit within 12 weeks time frame)
  • Global improvement scale(During each follow up visit within 12 weeks time frame)
  • EuroQol(During each follow up visit within 12 weeks time frame)
  • Modified Ashworth Scale (MAS)(During each follow up visit within 12 weeks time frame)
  • Self-report spasticity symptoms(During each follow up visit within 12 weeks time frame)
  • Extended Activities of Daily Living(During each follow up visit within 12 weeks time frame)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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