Skip to main content
OpenTrials
Completed

NCT Number: NCT04581551

Reliability and Validity Study for SWE of 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Ghent, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SWE assessor 1

Procedure

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

Procedure

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

Procedure

Transversal stretch of pectoralis major muscle on the hemiplegic side.

No stretch intervention

Procedure

Passive mobilisation of the hemiplegic hand.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: SWE_stroke

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.