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

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

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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Procedure: SWE assessor 1; Procedure: SWE assessor 2; Procedure: Stretch intervention; Procedure: No stretch intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Ghent, Belgium, 9000
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke group; 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; SWE for 6 shoulder muscles will be performed.; m. supraspinatus; m. infraspinatus; m. rhomboideus major; m. deltoideus; m. pectoralis major; m. pectoralis minor; Procedure: SWE 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; Procedure: Stretch intervention; Transversal stretch of pectoralis major muscle on the hemiplegic side.; Procedure: No stretch intervention; Passive mobilisation of the hemiplegic hand.
Active Comparator: Healthy controls; 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; SWE for 6 shoulder muscles will be performed.; m. supraspinatus; m. infraspinatus; m. rhomboideus major; m. deltoideus; m. pectoralis major; m. pectoralis minor

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subcutaneous tissue thickness	Measurement de thickness of the subcutaneous layer on the ultrasound image of the m. pectoralis major to compare the stroke group and healthy control group.	Single point of assessment on day 1

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Annelies Maenhout, Prof, University Ghent; Principal Investigator: Kristine Oostra, Prof, University Hospital, Ghent; Principal Investigator: Dirk Cambier, Prof, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Shoulder pain; Shear wave elastography; Shoulder muscles
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B6702020000601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No