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

NCT ID: NCT04550793

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

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

Botulinum toxin injection

Intervention Type: DRUG

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.

No interventions assigned to this group

Interventions

Botulinum toxin injection

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huey-Wen Liang, MD PHD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Huey-Wen Liang, MD PHD

Role: CONTACT

ntuhpmr.4124@gmail.com

886-2-23123456 ext. 66697

Other Identifiers

202006138RINB

Identifier Type: -

Identifier Source: org_study_id