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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Spasticity, Muscle; Ultrasound; Botulism; Activity of Daily Living
• Intervention / Treatment: Drug: Botulinum toxin injection

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Huey-Wen Liang, MD PHD; Phone Number: 66697 886-2-23123456; Email: ntuhpmr.4124@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stroke patient aged above 20 years old with unilateral involvement.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials.	Drug: Botulinum toxin injection; Botulinum toxin injection at affected brachialis and/or biceps brachials.
Control; 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?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Huey-Wen Liang, MD PHD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Foodborne Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Neuromuscular Junction Diseases; Clostridium Infections; Muscle Hypertonia; Poisoning; Neurotoxicity Syndromes; Stroke; Muscle Spasticity; Botulism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 202006138RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No