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

NCT04550793 | Unknown

• 1 other identifier: 202006138RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• Stroke Rehabilitation Assessment of Movement (STREAM), brief version

  During each follow up visit within 12 weeks time frame

• Modified Ashworth Scale (MAS)

  During each follow up visit within 12 weeks time frame

• Tone Assessment Scale (TAS)

  During each follow up visit within 12 weeks time frame

Study Arms (2)

Intervention

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

Drug: Botulinum toxin injection

Control

The stroke patients who do not receive botulinum toxin injection at affected brachialis and/or biceps brachials in the past 3 months.

Interventions

Botulinum toxin injection DRUG

Botulinum toxin injection at affected brachialis and/or biceps brachials.

Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patient aged above 20 years old with unilateral involvement.

You may qualify if:

• \[Intervention group\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Botulism

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuromuscular Junction Diseases; Neuromuscular Diseases; Neurotoxicity Syndromes; Foodborne Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Huey-Wen Liang, MD PHD

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Huey-Wen Liang, MD PHD

CONTACT

886-2-23123456; ntuhpmr.4124@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)