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CompletedNCT04581551SWE_strokeUpdated Dec 14, 2022

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

An interventional study of SWE assessor 1 and SWE assessor 2 in Stroke, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).
Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • Shear wave elastography
  • Shoulder muscles
  • Shoulder pain
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 23 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Stroke group

Inclusion criteria

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
23 participants (actual)

Study arms

  • 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 · Procedure: SWE assessor 2 · Procedure: Stretch intervention · Procedure: No stretch intervention

  • 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

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.

06

What researchers measure

Primary outcomes

  1. SWV m. supraspinatus

    Shear wave velocity of the m. supraspinatus

    Time frame: Single point of assessment on day 1 (test)

  2. SWV m. supraspinatus

    Shear wave velocity of the m. supraspinatus

    Time frame: Single point of assessment on day 2 (retest)

  3. SWV m. infraspinatus

    Shear wave velocity of the m. infraspinatus

    Time frame: Single point of assessment on day 1 (test)

  4. SWV m. infraspinatus

    Shear wave velocity of the m. infraspinatus

    Time frame: Single point of assessment on day 2 (retest)

  5. SWV m. rhomboideus major

    Shear wave velocity of the m. rhomboideus major

    Time frame: Single point of assessment on day 1 (test)

  6. SWV m. rhomboideus major

    Shear wave velocity of the m. rhomboideus major

    Time frame: Single point of assessment on day 2 (retest)

  7. SWV m. deltoideus

    Shear wave velocity of the m. deltoideus

    Time frame: Single point of assessment on day 1 (test)

  8. SWV m. deltoideus

    Shear wave velocity of the m. deltoideus

    Time frame: Single point of assessment on day 2 (retest)

  9. SWV m. pectoralis major

    Shear wave velocity of the m. pectoralis major

    Time frame: Single point of assessment on day 1 (test)

  10. SWV m. pectoralis major

    Shear wave velocity of the m. pectoralis major

    Time frame: Single point of assessment on day 2 (retest)

  11. SWV m. pectoralis minor

    Shear wave velocity of the m. pectoralis minor

    Time frame: Single point of assessment on day 1 (test)

  12. SWV m. pectoralis minor

    Shear wave velocity of the m. pectoralis minor

    Time frame: Single point of assessment on day 2 (retest)

Secondary outcomes

  1. Demographic variables

    Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis

    Time frame: Baseline assessment day 1

  2. Passive range of motion of shoulder

    Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)

    Time frame: Baseline assessment day 1

  3. 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

    Time frame: Assessment day 1

  4. Shoulder subluxation - ultrasound measurement

    Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted

    Time frame: Assessment day 1

  5. Fugl-Meyer assessment upper limb section

    Active recovery of the upper limb motor function

    Time frame: Assessment day 1

  6. Subjective feeling of shoulder stiffness

    Question to the patients about how stiff the shoulder feels

    Time frame: Assessment day 1

  7. Sports before stroke

    Question if stroke patients performed sports before stroke and which sports they performed before stroke

    Time frame: Assessment day 1

Other outcomes

  1. 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.

    Time frame: Single point of assessment on day 1

07

Study locations

2 sites
  • Ghent University Hospital
    Ghent, 9000, Belgium
  • Ghent University
    Ghent, 9000, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04581551
Lead sponsor
University Hospital, Ghent
Collaborators
University Ghent
Responsible party
Sponsor
First posted
Oct 9, 2020
Start date
Oct 5, 2020
Primary completion
Sep 27, 2021
Completion
Sep 27, 2021
Last update
Dec 14, 2022

Study contacts

Annelies Maenhout, Prof
principal investigator · University Ghent
Kristine Oostra, Prof
principal investigator · University Hospital, Ghent
Dirk Cambier, Prof
principal investigator · University Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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