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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Spasticity, Muscle, Botulism, Ultrasound, Activity of Daily Living

Intervention / Treatment
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* Drug: Botulinum toxin injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials. | Drug: Botulinum toxin injection<br>* Botulinum toxin injection at affected brachialis and/or biceps brachials.<br>|
| Control<br>The stroke patients who do not receive botulinum toxin injection at affected brachialis and/or biceps brachials in the past 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shear Wave Ultrasound Elastography | Shear wave ultrasound elastography measurement of spastic upper limb muscles, including biceps brachii and brachialis | During each follow up visit within 12 weeks time frame | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index (Wade's version) | Barthel Index assessing activities of daily livings | During each follow up visit within 12 weeks time frame | 
| Revised Nottingham Extended Activities of Daily Livings Scale | Revised Nottingham Extended Scale assessing activities of daily livings | During each follow up visit within 12 weeks time frame | 
| Stroke Rehabilitation Assessment of Movement (STREAM), brief version | STREAM assessing movement condition | During each follow up visit within 12 weeks time frame | 
| Modified Ashworth Scale (MAS) | MAS scale for assessing spasticity | During each follow up visit within 12 weeks time frame | 
| Tone Assessment Scale (TAS) | TAS scale for assessing spasticity | During each follow up visit within 12 weeks time frame | 
| Global improvement scale | Global improvement scale for assessing symptoms related to stroke | During each follow up visit within 12 weeks time frame | 
| Self-report spasticity symptoms | Self-report spasticity symptoms for assessing spasticity | During each follow up visit within 12 weeks time frame | 
| EuroQol | EuroQol for evaluating quality of life | During each follow up visit within 12 weeks time frame | 
| Extended Activities of Daily Living | Extended Activities of Daily Living scale for evaluating activity of daily living | During each follow up visit within 12 weeks time frame | 
| Postural Assessment Scale for Stroke Patients (PASS), brief version | PASS for evaluating symptoms related to stroke | During each follow up visit within 12 weeks time frame |