Clinical trial NCT02557711: The Findings of Ultrasound Elastography and ARFI in Strokes Patients With Spastic Elbow Flexor
Official title: The Correlation Between Clinical Examination and Ultrasound Elastography Acoustic Radiation Force Impulse Findings in Hemiplegic Patients With Elbow Flexor Spasticity After Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Accident
Keywords: spasticity
stroke
ultrasound elastography
acoustic radiation force impulse
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: refer from physiatrists in Kaohsiung 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)
timeFrame: patients will be evaluated within 1 month after basic history taking and consent signing
Secondary outcomes:
measure: the thickness of biceps brachii
timeFrame: patients will be evaluated within 1 month after basic history taking and signing consent
measure: Heckmatt scale
timeFrame: patients will be evaluated within 1 month after finishing history taking and consent signing
measure: strain ratio
timeFrame: patients will be evaluated within 1 month after finishing history taking and consent signing
measure: Dynamic Sonoelastography Score(DS score)
timeFrame: patients will be evaluated within 1 month after finishing history taking and consent signing
measure: The mean values of the intensity of red, green, and blue on histogram of bicep brachii
timeFrame: patients will be evaluated within 1 month after finishing history taking and consent signing
measure: shear wave velocity within region of interest between biceps brachii and brachialis
timeFrame: patients will be evaluated within 1 month after finishing history taking and consent signing
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Rehabilitation
name: Pong Ya-Ping, MD
role: STUDY_CHAIR
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