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

• ClinicalTrials.gov Identifier: NCT04581551
• Recruitment Status: Recruiting
• First Posted: October 9, 2020
• Last Update Posted: April 8, 2021
• Sponsor: University Hospital, Ghent
• Collaborator: University Ghent
• Information provided by (Responsible Party): University Hospital, Ghent

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stroke	Procedure: SWE assessor 1; Procedure: SWE assessor 2; Procedure: Stretch intervention; Procedure: No stretch intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Reliability and Validity Study to Assess the Test-retest and Intra-rater Reliability of SWE in Shoulder Muscles in Persons After Stroke.
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: October 10, 2021
• Estimated Study Completion Date: October 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. SWV m. supraspinatus [ Time Frame: Single point of assessment on day 1 (test) ]
   Shear wave velocity of the m. supraspinatus
2. SWV m. supraspinatus [ Time Frame: Single point of assessment on day 2 (retest) ]
   Shear wave velocity of the m. supraspinatus
3. SWV m. infraspinatus [ Time Frame: Single point of assessment on day 1 (test) ]
   Shear wave velocity of the m. infraspinatus
4. SWV m. infraspinatus [ Time Frame: Single point of assessment on day 2 (retest) ]
   Shear wave velocity of the m. infraspinatus
5. SWV m. rhomboideus major [ Time Frame: Single point of assessment on day 1 (test) ]
   Shear wave velocity of the m. rhomboideus major
6. SWV m. rhomboideus major [ Time Frame: Single point of assessment on day 2 (retest) ]
   Shear wave velocity of the m. rhomboideus major
7. SWV m. deltoideus [ Time Frame: Single point of assessment on day 1 (test) ]
   Shear wave velocity of the m. deltoideus
8. SWV m. deltoideus [ Time Frame: Single point of assessment on day 2 (retest) ]
   Shear wave velocity of the m. deltoideus
9. SWV m. pectoralis major [ Time Frame: Single point of assessment on day 1 (test) ]
   Shear wave velocity of the m. pectoralis major
10. SWV m. pectoralis major [ Time Frame: Single point of assessment on day 2 (retest) ]
    Shear wave velocity of the m. pectoralis major
11. SWV m. pectoralis minor [ Time Frame: Single point of assessment on day 1 (test) ]
    Shear wave velocity of the m. pectoralis minor
12. SWV m. pectoralis minor [ Time Frame: Single point of assessment on day 2 (retest) ]
    Shear wave velocity of the m. pectoralis minor

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Subcutaneous tissue thickness [ Time Frame: Single point of assessment on day 1 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Anke Van Bladel, PhD; 093324657; anke.vanbladel@ugent.be

Locations

Belgium

Ghent University Hospital; Recruiting

Ghent, Belgium, 9000

Contact: Kristine Oostra, Prof 093325983 kristine.oostra@uzgent.be

Ghent University; Recruiting

Ghent, Belgium, 9000

Contact: Anke Van Bladel, PhD 093324657 anke.vanbladel@ugent.be

Sponsors and Collaborators

University Hospital, Ghent

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

More Information

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04581551
• Other Study ID Numbers: B6702020000601
• First Posted: October 9, 2020
• Last Update Posted: April 8, 2021
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Ghent:

Stroke; Shear wave elastography; Shoulder muscles; Shoulder pain

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases