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

Study Overview
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Brief Summary
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This study aims To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke. 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). 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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Procedure: SWE assessor 1
* Procedure: SWE assessor 2
* Procedure: Stretch intervention
* Procedure: No stretch intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke group<br>SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor | Procedure: SWE assessor 1<br>* SWE for 6 shoulder muscles will be performed. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor<br>Procedure: SWE assessor 2<br>* SWE for 6 shoulder muscles will be performed. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor<br>Procedure: Stretch intervention<br>* Transversal stretch of pectoralis major muscle on the hemiplegic side.<br>Procedure: No stretch intervention<br>* Passive mobilisation of the hemiplegic hand.<br>|
| Active Comparator: Healthy controls<br>SWE for 6 shoulder muscles will be performed by 1 assessors. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor | Procedure: SWE assessor 1<br>* SWE for 6 shoulder muscles will be performed. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SWV m. supraspinatus | Shear wave velocity of the m. supraspinatus | Single point of assessment on day 1 (test) | 
| SWV m. supraspinatus | Shear wave velocity of the m. supraspinatus | Single point of assessment on day 2 (retest) | 
| SWV m. infraspinatus | Shear wave velocity of the m. infraspinatus | Single point of assessment on day 1 (test) | 
| SWV m. infraspinatus | Shear wave velocity of the m. infraspinatus | Single point of assessment on day 2 (retest) | 
| SWV m. rhomboideus major | Shear wave velocity of the m. rhomboideus major | Single point of assessment on day 1 (test) | 
| SWV m. rhomboideus major | Shear wave velocity of the m. rhomboideus major | Single point of assessment on day 2 (retest) | 
| SWV m. deltoideus | Shear wave velocity of the m. deltoideus | Single point of assessment on day 1 (test) | 
| SWV m. deltoideus | Shear wave velocity of the m. deltoideus | Single point of assessment on day 2 (retest) | 
| SWV m. pectoralis major | Shear wave velocity of the m. pectoralis major | Single point of assessment on day 1 (test) | 
| SWV m. pectoralis major | Shear wave velocity of the m. pectoralis major | Single point of assessment on day 2 (retest) | 
| SWV m. pectoralis minor | Shear wave velocity of the m. pectoralis minor | Single point of assessment on day 1 (test) | 
| SWV m. pectoralis minor | Shear wave velocity of the m. pectoralis minor | Single point of assessment on day 2 (retest) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Shear wave elastography, Shoulder muscles, Shoulder pain