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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04550793
• Other study ID #: 202006138RINB
• Status: Not yet recruiting
• Start date: September 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: National Taiwan University Hospital
• Contact: Huey-Wen Liang, MD PHD
• Phone: 886-2-23123456
• Email: ntuhpmr.4124[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Barthel Index (Wade's version)	Barthel Index assessing activities of daily livings	During each follow up visit within 12 weeks time frame
Secondary	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
Secondary	Stroke Rehabilitation Assessment of Movement (STREAM), brief version	STREAM assessing movement condition	During each follow up visit within 12 weeks time frame
Secondary	Modified Ashworth Scale (MAS)	MAS scale for assessing spasticity	During each follow up visit within 12 weeks time frame
Secondary	Tone Assessment Scale (TAS)	TAS scale for assessing spasticity	During each follow up visit within 12 weeks time frame
Secondary	Global improvement scale	Global improvement scale for assessing symptoms related to stroke	During each follow up visit within 12 weeks time frame
Secondary	Self-report spasticity symptoms	Self-report spasticity symptoms for assessing spasticity	During each follow up visit within 12 weeks time frame
Secondary	EuroQol	EuroQol for evaluating quality of life	During each follow up visit within 12 weeks time frame
Secondary	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
Secondary	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