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Clinical Trials/NCT04581551
NCT04581551
Completed
Not Applicable

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

University Hospital, Ghent2 sites in 1 country23 target enrollmentOctober 5, 2020
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital, Ghent
Enrollment
23
Locations
2
Primary Endpoint
SWV m. infraspinatus
Status
Completed
Last Updated
3 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2020
End Date
September 27, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

SWV m. infraspinatus

Time Frame: Single point of assessment on day 2 (retest)

Shear wave velocity of the m. infraspinatus

SWV m. pectoralis major

Time Frame: Single point of assessment on day 2 (retest)

Shear wave velocity of the m. pectoralis major

SWV m. supraspinatus

Time Frame: Single point of assessment on day 2 (retest)

Shear wave velocity of the m. supraspinatus

SWV m. deltoideus

Time Frame: Single point of assessment on day 2 (retest)

Shear wave velocity of the m. deltoideus

SWV m. pectoralis minor

Time Frame: Single point of assessment on day 2 (retest)

Shear wave velocity of the m. pectoralis minor

SWV m. rhomboideus major

Time Frame: Single point of assessment on day 2 (retest)

Shear wave velocity of the m. rhomboideus major

Secondary Outcomes

  • Sports before stroke(Assessment day 1)
  • Passive range of motion of shoulder(Baseline assessment day 1)
  • Spasticity shoulder muscles(Assessment day 1)
  • Shoulder subluxation - ultrasound measurement(Assessment day 1)
  • Subjective feeling of shoulder stiffness(Assessment day 1)
  • Demographic variables(Baseline assessment day 1)
  • Fugl-Meyer assessment upper limb section(Assessment day 1)

Study Sites (2)

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