Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04581551
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2020-09-09
Brief Title:
Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Reliability and Validity Study to Assess the Test-retest and Intra-rater Reliability of SWE in Shoulder Muscles in Persons After Stroke
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWE_stroke
Brief 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
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None