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Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.

Reliability and Validity Study to Assess the Test-retest and Intra-rater Reliability of SWE in Shoulder Muscles in Persons After Stroke.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04581551
Acronym
SWE_stroke
Enrollment
23
Registered
2020-10-09
Start date
2020-10-05
Completion date
2021-09-27
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Shear wave elastography, Shoulder muscles, Shoulder pain

Brief summary

This study aims 1. To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke. 2. To assess if differentiation can be made between the hemiplegic (HP) and non-hemiplegic (NHP) side and between stroke patients and matched healthy volunteers (discriminative validity). 3. To assess if an immediate effect on the pectoralis major and minor can be measured after applying transversal stretch technique to the pectoralis major muscles (response validity).

Detailed description

Stroke patients will be assessed on 2 days with an interval of 3 days (Friday - Monday). Day 1 (Friday): shear wave velocity (SWV) will be assessed by 2 assessors in randomised order. Each assessor will evaluate SWV of 6 shoulder muscles (m. supraspinatus, m. infraspinatus, m. rhomboid major, m. deltoideus, m. pectoralis major, m. pectoralis minor). At the end of the assessment secondary outcome measures will be assessed. Day 2 (Monday): SWV will be reassessed by assessor 1 to measure test-retest reliability. Position of the patient will be changed. SWV of the pectoralis major and minor muscle will be reassessed. Assessor 2 will perform a transversal stretch of the m. pectoralis major or a passive mobilisation of the hand at the hemiplegic arm of the stroke patients. Assessor 1 will reassess the SWV of the pectoralis major and minor muscle to assess if there is an immediate effect of the intervention. Assessor 1 will be blinded for the intervention. Healthy controls (matched for age, gender and BMI): Only one test day to assess SWV of 6 shoulder muscles. Secondary outcome measures will be assessed after SWE assessment.

Interventions

PROCEDURESWE assessor 1

SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor

PROCEDURESWE assessor 2

SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor

PROCEDUREStretch intervention

Transversal stretch of pectoralis major muscle on the hemiplegic side.

PROCEDURENo stretch intervention

Passive mobilisation of the hemiplegic hand.

Sponsors

University Ghent
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Stroke group Inclusion: * Stroke patients in the subacute phase after stroke (\< 6 months post stroke) * Able to sit independently with support of the back, but without support of the arms * With upper-limb (UL) impairment: i.e. no maximum score (36) on the shoulder elbow part of the Fugl-Meyer UL (FM UL)

Exclusion criteria

* Other neurologic disorders * Shoulder or neck surgery before stroke onset * Arthroscopic surgery in the last year before stroke onset. * Shoulder or neck pain in the last year before stroke onset. * Severe cognitive or language deficits that inhibit the participants of understanding simple commands or providing valuable information regarding the outcome measures - measured with the Ability Q. * Participants who are not able to maintain the test position. * Pregnancy Healthy controls can participate if they * Have not suffered a stroke or other neurological disorders * Did not have surgery at the shoulder and/or neck * Did not have arthroscopic surgery in the last year before stroke * If they do not suffer any shoulder or neck pain

Design outcomes

Primary

MeasureTime frameDescription
SWV m. pectoralis minorSingle point of assessment on day 1 (test)Shear wave velocity of the m. pectoralis minor
SWV m. supraspinatusSingle point of assessment on day 1 (test)Shear wave velocity of the m. supraspinatus
SWV m. infraspinatusSingle point of assessment on day 1 (test)Shear wave velocity of the m. infraspinatus
SWV m. rhomboideus majorSingle point of assessment on day 1 (test)Shear wave velocity of the m. rhomboideus major
SWV m. deltoideusSingle point of assessment on day 1 (test)Shear wave velocity of the m. deltoideus
SWV m. pectoralis majorSingle point of assessment on day 1 (test)Shear wave velocity of the m. pectoralis major

Secondary

MeasureTime frameDescription
Subjective feeling of shoulder stiffnessAssessment day 1Question to the patients about how stiff the shoulder feels
Sports before strokeAssessment day 1Question if stroke patients performed sports before stroke and which sports they performed before stroke
Demographic variablesBaseline assessment day 1Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis
Passive range of motion of shoulderBaseline assessment day 1Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)
Spasticity shoulder musclesAssessment day 1Modified Ashworth Scale (minimum 0 - maximum 4, higher score is more spasticity = worse outcome) of shoulder flexors, extensors, internal rotators, external rotators, adductors, abductors
Shoulder subluxation - ultrasound measurementAssessment day 1Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted
Fugl-Meyer assessment upper limb sectionAssessment day 1Active recovery of the upper limb motor function

Other

MeasureTime frameDescription
Subcutaneous tissue thicknessSingle point of assessment on day 1Measurement de thickness of the subcutaneous layer on the ultrasound image of the m. pectoralis major to compare the stroke group and healthy control group.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026