Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.
NCT ID: NCT04581551
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2020-10-05
2021-09-27
Brief Summary
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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).
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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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
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.
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
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
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Annelies Maenhout, Prof
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Kristine Oostra, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Dirk Cambier, Prof
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Ghent University
Ghent, , Belgium
Countries
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Other Identifiers
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B6702020000601
Identifier Type: -
Identifier Source: org_study_id