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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SWE assessor 1
SWE assessor 2
Stretch intervention
No stretch intervention
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stroke focused on measuring Stroke, Shear wave elastography, Shoulder muscles, Shoulder pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ghent University Hospital
  • Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke group

Healthy controls

Arm Description

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 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

Outcomes

Primary Outcome Measures

SWV m. supraspinatus
Shear wave velocity of the m. supraspinatus
SWV m. supraspinatus
Shear wave velocity of the m. supraspinatus
SWV m. infraspinatus
Shear wave velocity of the m. infraspinatus
SWV m. infraspinatus
Shear wave velocity of the m. infraspinatus
SWV m. rhomboideus major
Shear wave velocity of the m. rhomboideus major
SWV m. rhomboideus major
Shear wave velocity of the m. rhomboideus major
SWV m. deltoideus
Shear wave velocity of the m. deltoideus
SWV m. deltoideus
Shear wave velocity of the m. deltoideus
SWV m. pectoralis major
Shear wave velocity of the m. pectoralis major
SWV m. pectoralis major
Shear wave velocity of the m. pectoralis major
SWV m. pectoralis minor
Shear wave velocity of the m. pectoralis minor
SWV m. pectoralis minor
Shear wave velocity of the m. pectoralis minor

Secondary Outcome Measures

Demographic variables
Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis
Passive range of motion of shoulder
Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)
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
Shoulder subluxation - ultrasound measurement
Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted
Fugl-Meyer assessment upper limb section
Active recovery of the upper limb motor function
Subjective feeling of shoulder stiffness
Question to the patients about how stiff the shoulder feels
Sports before stroke
Question if stroke patients performed sports before stroke and which sports they performed before stroke

Full Information

First Posted
September 9, 2020
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04581551
Brief Title
Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Shear wave elastography, Shoulder muscles, Shoulder pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke group
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
SWE assessor 1
Intervention Description
SWE for 6 shoulder muscles will be performed. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor
Intervention Type
Procedure
Intervention Name(s)
SWE assessor 2
Intervention Description
SWE for 6 shoulder muscles will be performed. m. supraspinatus m. infraspinatus m. rhomboideus major m. deltoideus m. pectoralis major m. pectoralis minor
Intervention Type
Procedure
Intervention Name(s)
Stretch intervention
Intervention Description
Transversal stretch of pectoralis major muscle on the hemiplegic side.
Intervention Type
Procedure
Intervention Name(s)
No stretch intervention
Intervention Description
Passive mobilisation of the hemiplegic hand.
Primary Outcome Measure Information:
Title
SWV m. supraspinatus
Description
Shear wave velocity of the m. supraspinatus
Time Frame
Single point of assessment on day 1 (test)
Title
SWV m. supraspinatus
Description
Shear wave velocity of the m. supraspinatus
Time Frame
Single point of assessment on day 2 (retest)
Title
SWV m. infraspinatus
Description
Shear wave velocity of the m. infraspinatus
Time Frame
Single point of assessment on day 1 (test)
Title
SWV m. infraspinatus
Description
Shear wave velocity of the m. infraspinatus
Time Frame
Single point of assessment on day 2 (retest)
Title
SWV m. rhomboideus major
Description
Shear wave velocity of the m. rhomboideus major
Time Frame
Single point of assessment on day 1 (test)
Title
SWV m. rhomboideus major
Description
Shear wave velocity of the m. rhomboideus major
Time Frame
Single point of assessment on day 2 (retest)
Title
SWV m. deltoideus
Description
Shear wave velocity of the m. deltoideus
Time Frame
Single point of assessment on day 1 (test)
Title
SWV m. deltoideus
Description
Shear wave velocity of the m. deltoideus
Time Frame
Single point of assessment on day 2 (retest)
Title
SWV m. pectoralis major
Description
Shear wave velocity of the m. pectoralis major
Time Frame
Single point of assessment on day 1 (test)
Title
SWV m. pectoralis major
Description
Shear wave velocity of the m. pectoralis major
Time Frame
Single point of assessment on day 2 (retest)
Title
SWV m. pectoralis minor
Description
Shear wave velocity of the m. pectoralis minor
Time Frame
Single point of assessment on day 1 (test)
Title
SWV m. pectoralis minor
Description
Shear wave velocity of the m. pectoralis minor
Time Frame
Single point of assessment on day 2 (retest)
Secondary Outcome Measure Information:
Title
Demographic variables
Description
Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis
Time Frame
Baseline assessment day 1
Title
Passive range of motion of shoulder
Description
Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)
Time Frame
Baseline assessment day 1
Title
Spasticity shoulder muscles
Description
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
Title
Shoulder subluxation - ultrasound measurement
Description
Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted
Time Frame
Assessment day 1
Title
Fugl-Meyer assessment upper limb section
Description
Active recovery of the upper limb motor function
Time Frame
Assessment day 1
Title
Subjective feeling of shoulder stiffness
Description
Question to the patients about how stiff the shoulder feels
Time Frame
Assessment day 1
Title
Sports before stroke
Description
Question if stroke patients performed sports before stroke and which sports they performed before stroke
Time Frame
Assessment day 1
Other Pre-specified Outcome Measures:
Title
Subcutaneous tissue thickness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelies Maenhout, Prof
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristine Oostra, Prof
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Cambier, Prof
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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