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

• Conditions: Cerebrovascular Accident

• Registration Number: NCT02557711
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-30
• Study Start: 2016-06
• Primary Completion: 2017-05
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)	patients will be evaluated within 1 month after basic history taking and consent signing

Secondary Outcome Measures

Name	Time	Method
Dynamic Sonoelastography Score(DS score)	patients will be evaluated within 1 month after finishing history taking and consent signing
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
Heckmatt scale	patients will be evaluated within 1 month after finishing history taking and consent signing
strain ratio	patients will be evaluated within 1 month after finishing history taking and consent signing
the thickness of biceps brachii	patients will be evaluated within 1 month after basic history taking and signing consent
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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan