The Findings of Ultrasound Elastography and ARFI in Strokes Patients With Spastic Elbow Flexor

Cerebrovascular Accident Clinical Trial

Official title:

The Correlation Between Clinical Examination and Ultrasound Elastography Acoustic Radiation Force Impulse Findings in Hemiplegic Patients With Elbow Flexor Spasticity After Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02557711
• Other study ID #: CMRPG8D0951
• Status: Not yet recruiting
• Phase: N/A
• First received: September 17, 2015
• Last updated: March 28, 2016
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Chang Gung Memorial Hospital
• Contact: Pong Ya-Ping, MD
• Phone: 889-7-7317123
• Email: yaping0707[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/ ARFI imaging in spasticity evaluation of stroke patients.

Description:

Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS) are the most commonly used tools for spasticity assessment. But these clinic methods cannot reveal the architecture and stiffness of muscles. In recent years, ultrasound elastography and acoustic radiation force impulse (ARFI) are used in musculoskeletal disorders, including spasticity. There are no studies about the correlation between spasticity and ultrasound elastography /ARFI imaging in stroke patients. The investigators will enroll 50 stroke patients with hemiplegia and biceps brachii muscle spasticity. One physical therapist will measure MAS and MTS for spasticity of biceps brachii muscle. Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation. The evaluations of B-mode ultrasound, elastography and ARFI included Heckmatt scale, biceps brachii ratio, strain ratio, dynamic sonoelastography score, color intensity, and shear wave velocity. After performing all assessments, the investigators will analyze the correlation between the clinic tools and elastography/ ARFI imaging and evaluate the reliability of elastography/ ARFI imaging in spasticity evaluation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• stroke patients with hemiplegia and biceps brachii muscle spasticity.

Exclusion Criteria:

• elbow joint contracture deformity

• combined other neuromuscular system disease

• affected upper extremity has local infection

• patient who can't follow instruction, who is restlessness and whose elbow can't meet the positioning criteria

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• ultrasound elastography, acoustic radiation force impulse
Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)		patients will be evaluated within 1 month after basic history taking and consent signing	No
Secondary	the thickness of biceps brachii		patients will be evaluated within 1 month after basic history taking and signing consent	No
Secondary	Heckmatt scale		patients will be evaluated within 1 month after finishing history taking and consent signing	No
Secondary	strain ratio		patients will be evaluated within 1 month after finishing history taking and consent signing	No
Secondary	Dynamic Sonoelastography Score(DS score)		patients will be evaluated within 1 month after finishing history taking and consent signing	No
Secondary	The mean values of the intensity of red, green, and blue on histogram of bicep brachii		patients will be evaluated within 1 month after finishing history taking and consent signing	No
Secondary	shear wave velocity within region of interest between biceps brachii and brachialis		patients will be evaluated within 1 month after finishing history taking and consent signing	No