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

Stroke Clinical Trial

— SWE_stroke  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581551
• Other study ID #: B6702020000601
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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
• Stretch intervention
Transversal stretch of pectoralis major muscle on the hemiplegic side.
• No stretch intervention
Passive mobilisation of the hemiplegic hand.

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	SWV m. supraspinatus	Shear wave velocity of the m. supraspinatus	Single point of assessment on day 1 (test)
Primary	SWV m. supraspinatus	Shear wave velocity of the m. supraspinatus	Single point of assessment on day 2 (retest)
Primary	SWV m. infraspinatus	Shear wave velocity of the m. infraspinatus	Single point of assessment on day 1 (test)
Primary	SWV m. infraspinatus	Shear wave velocity of the m. infraspinatus	Single point of assessment on day 2 (retest)
Primary	SWV m. rhomboideus major	Shear wave velocity of the m. rhomboideus major	Single point of assessment on day 1 (test)
Primary	SWV m. rhomboideus major	Shear wave velocity of the m. rhomboideus major	Single point of assessment on day 2 (retest)
Primary	SWV m. deltoideus	Shear wave velocity of the m. deltoideus	Single point of assessment on day 1 (test)
Primary	SWV m. deltoideus	Shear wave velocity of the m. deltoideus	Single point of assessment on day 2 (retest)
Primary	SWV m. pectoralis major	Shear wave velocity of the m. pectoralis major	Single point of assessment on day 1 (test)
Primary	SWV m. pectoralis major	Shear wave velocity of the m. pectoralis major	Single point of assessment on day 2 (retest)
Primary	SWV m. pectoralis minor	Shear wave velocity of the m. pectoralis minor	Single point of assessment on day 1 (test)
Primary	SWV m. pectoralis minor	Shear wave velocity of the m. pectoralis minor	Single point of assessment on day 2 (retest)
Secondary	Demographic variables	Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis	Baseline assessment day 1
Secondary	Passive range of motion of shoulder	Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)	Baseline assessment day 1
Secondary	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
Secondary	Shoulder subluxation - ultrasound measurement	Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted	Assessment day 1
Secondary	Fugl-Meyer assessment upper limb section	Active recovery of the upper limb motor function	Assessment day 1
Secondary	Subjective feeling of shoulder stiffness	Question to the patients about how stiff the shoulder feels	Assessment day 1
Secondary	Sports before stroke	Question if stroke patients performed sports before stroke and which sports they performed before stroke	Assessment day 1