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

• Conditions: Botulism; Activity of Daily Living; Spasticity, Muscle; Ultrasound; Stroke
• Interventions: Drug: Botulinum toxin injection

• Registration Number: NCT04550793
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-09
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Shear Wave Ultrasound Elastography	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan