Clinical trial NCT04581551: Reliability and Validity Study for SWE of Shoulder Muscles in Persons After 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Shear wave elastography
Shoulder muscles
Shoulder pain
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2020-10-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: SWV m. supraspinatus
timeFrame: Single point of assessment on day 1 (test)
measure: SWV m. supraspinatus
timeFrame: Single point of assessment on day 2 (retest)
measure: SWV m. infraspinatus
timeFrame: Single point of assessment on day 1 (test)
measure: SWV m. infraspinatus
timeFrame: Single point of assessment on day 2 (retest)
measure: SWV m. rhomboideus major
timeFrame: Single point of assessment on day 1 (test)
measure: SWV m. rhomboideus major
timeFrame: Single point of assessment on day 2 (retest)
measure: SWV m. deltoideus
timeFrame: Single point of assessment on day 1 (test)
measure: SWV m. deltoideus
timeFrame: Single point of assessment on day 2 (retest)
measure: SWV m. pectoralis major
timeFrame: Single point of assessment on day 1 (test)
measure: SWV m. pectoralis major
timeFrame: Single point of assessment on day 2 (retest)
measure: SWV m. pectoralis minor
timeFrame: Single point of assessment on day 1 (test)
measure: SWV m. pectoralis minor
timeFrame: Single point of assessment on day 2 (retest)
Secondary outcomes:
measure: Demographic variables
timeFrame: Baseline assessment day 1
measure: Passive range of motion of shoulder
timeFrame: Baseline assessment day 1
measure: Spasticity shoulder muscles
timeFrame: Assessment day 1
measure: Shoulder subluxation - ultrasound measurement
timeFrame: Assessment day 1
measure: Fugl-Meyer assessment upper limb section
timeFrame: Assessment day 1
measure: Subjective feeling of shoulder stiffness
timeFrame: Assessment day 1
measure: Sports before stroke
timeFrame: Assessment day 1
Other outcomes:
measure: Subcutaneous tissue thickness
timeFrame: Single point of assessment on day 1
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Annelies Maenhout, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Kristine Oostra, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Dirk Cambier, Prof
role: PRINCIPAL_INVESTIGATOR
References: