StrokeSWE_strokeNCT04581551
Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.
A study testing SWE assessor 1, SWE assessor 2 and Stretch intervention in people with Stroke, run by University Hospital, Ghent at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- SWE assessor 1, SWE assessor 2 and Stretch intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesBelgium
- Study dates
- 5 Oct 2020to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital
Ghent, 9000
Ghent University
Ghent, 9000
About this study
Official title: 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
- To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke.
- 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).
- 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.
- Conditions
- Stroke
- Being tested
- SWE assessor 1, SWE assessor 2, Stretch intervention, No stretch intervention
- Keywords
- Stroke, Shear wave elastography, Shoulder muscles, Shoulder pain
- Medical subject headings
- Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWE assessor 1Procedure or surgery
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 2Procedure or surgery
SWE for 6 shoulder muscles will be performed.
- m. supraspinatus
- m. infraspinatus
- m. rhomboideus major
- m. deltoideus
- m. pectoralis major
- m. pectoralis minor
Stretch interventionProcedure or surgery
Transversal stretch of pectoralis major muscle on the hemiplegic side.
No stretch interventionProcedure or surgery
Passive mobilisation of the hemiplegic hand.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | Experimental | 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 Receives: Procedure: SWE assessor 1; Procedure: SWE assessor 2; Procedure: Stretch intervention; Procedure: No stretch intervention |
| Healthy controls | Active comparator | 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 Receives: Procedure: SWE assessor 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SWV m. supraspinatus
Shear wave velocity of the m. supraspinatus
Measured: Single point of assessment on day 1 (test)
SWV m. supraspinatus
Shear wave velocity of the m. supraspinatus
Measured: Single point of assessment on day 2 (retest)
SWV m. infraspinatus
Shear wave velocity of the m. infraspinatus
Measured: Single point of assessment on day 1 (test)
SWV m. infraspinatus
Shear wave velocity of the m. infraspinatus
Measured: Single point of assessment on day 2 (retest)
SWV m. rhomboideus major
Shear wave velocity of the m. rhomboideus major
Measured: Single point of assessment on day 1 (test)
SWV m. rhomboideus major
Shear wave velocity of the m. rhomboideus major
Measured: Single point of assessment on day 2 (retest)
SWV m. deltoideus
Shear wave velocity of the m. deltoideus
Measured: Single point of assessment on day 1 (test)
SWV m. deltoideus
Shear wave velocity of the m. deltoideus
Measured: Single point of assessment on day 2 (retest)
SWV m. pectoralis major
Shear wave velocity of the m. pectoralis major
Measured: Single point of assessment on day 1 (test)
SWV m. pectoralis major
Shear wave velocity of the m. pectoralis major
Measured: Single point of assessment on day 2 (retest)
SWV m. pectoralis minor
Shear wave velocity of the m. pectoralis minor
Measured: Single point of assessment on day 1 (test)
SWV m. pectoralis minor
Shear wave velocity of the m. pectoralis minor
Measured: Single point of assessment on day 2 (retest)
Secondary outcomes (7)
Demographic variables
Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis
Measured: Baseline assessment day 1
Passive range of motion of shoulder
Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)
Measured: 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
Measured: Assessment day 1
Shoulder subluxation - ultrasound measurement
Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted
Measured: Assessment day 1
Fugl-Meyer assessment upper limb section
Active recovery of the upper limb motor function
Measured: Assessment day 1
Subjective feeling of shoulder stiffness
Question to the patients about how stiff the shoulder feels
Measured: Assessment day 1
Sports before stroke
Question if stroke patients performed sports before stroke and which sports they performed before stroke
Measured: Assessment day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start5 Oct 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Annelies Maenhout, Prof, Principal investigator, University GhentKristine Oostra, Prof, Principal investigator, University Hospital, GhentDirk Cambier, Prof, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581551
- Sponsor's protocol ID
- B6702020000601
- Acronym
- SWE_stroke
- Status last verified
- Jun 2022
- First submitted
- 9 Sep 2020
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity Study to Assess the Test-retest and Intra-rater Reliability of SWE in Shoulder Muscles in Persons After Stroke.
- ClinicalTrials.gov ID
- NCT04581551
- Acronym / sponsor ID
- SWE_stroke / B6702020000601
- Conditions
- Stroke
- Keywords
- Stroke, Shear wave elastography, Shoulder muscles, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims
- To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke.
- 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).
- 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).
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke group | Experimental | Procedure: SWE assessor 1, Procedure: SWE assessor 2, Procedure: Stretch intervention, Procedure: No stretch interventionSWE 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 |
| Healthy controls | Active comparator | Procedure: SWE assessor 1SWE 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWE assessor 1SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor | Procedure or surgery | Healthy controls, Stroke group |
| SWE assessor 2SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor | Procedure or surgery | Stroke group |
| Stretch interventionTransversal stretch of pectoralis major muscle on the hemiplegic side. | Procedure or surgery | Stroke group |
| No stretch interventionPassive mobilisation of the hemiplegic hand. | Procedure or surgery | Stroke group |
Primary outcome
SWV m. supraspinatus
Time frame: Single point of assessment on day 1 (test)
Shear wave velocity of the m. supraspinatus
SWV m. supraspinatus
Time frame: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. supraspinatus
SWV m. infraspinatus
Time frame: Single point of assessment on day 1 (test)
Shear wave velocity of the m. infraspinatus
SWV m. infraspinatus
Time frame: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. infraspinatus
SWV m. rhomboideus major
Time frame: Single point of assessment on day 1 (test)
Shear wave velocity of the m. rhomboideus major
SWV m. rhomboideus major
Time frame: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. rhomboideus major
SWV m. deltoideus
Time frame: Single point of assessment on day 1 (test)
Shear wave velocity of the m. deltoideus
SWV m. deltoideus
Time frame: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. deltoideus
SWV m. pectoralis major
Time frame: Single point of assessment on day 1 (test)
Shear wave velocity of the m. pectoralis major
SWV m. pectoralis major
Time frame: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. pectoralis major
SWV m. pectoralis minor
Time frame: Single point of assessment on day 1 (test)
Shear wave velocity of the m. pectoralis minor
SWV m. pectoralis minor
Time frame: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. pectoralis minor
7 secondary outcomes
Demographic variables
Time frame: Baseline assessment day 1
Passive range of motion of shoulder
Time frame: Baseline assessment day 1
Spasticity shoulder muscles
Time frame: Assessment day 1
Shoulder subluxation - ultrasound measurement
Time frame: Assessment day 1
Fugl-Meyer assessment upper limb section
Time frame: Assessment day 1
Subjective feeling of shoulder stiffness
Time frame: Assessment day 1
Sports before stroke
Time frame: Assessment day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelies Maenhout, Prof principal investigator
University Ghent
Kristine Oostra, Prof principal investigator
University Hospital, Ghent
Dirk Cambier, Prof principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWE assessor 1, SWE assessor 2 and Stretch intervention in people with Stroke, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SWV m. supraspinatus (time frame: Single point of assessment on day 1 (test)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.