Clinical Trials Directory

Trials / Completed

CompletedNCT04581551

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

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

Interventions

TypeNameDescription
PROCEDURESWE assessor 1SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor
PROCEDURESWE assessor 2SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor
PROCEDUREStretch interventionTransversal stretch of pectoralis major muscle on the hemiplegic side.
PROCEDURENo stretch interventionPassive mobilisation of the hemiplegic hand.

Timeline

Start date
2020-10-05
Primary completion
2021-09-27
Completion
2021-09-27
First posted
2020-10-09
Last updated
2022-12-14

Locations

2 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04581551. Inclusion in this directory is not an endorsement.