Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.
- Conditions
- Stroke
- Interventions
- Procedure: SWE assessor 1Procedure: SWE assessor 2Procedure: Stretch interventionProcedure: No stretch intervention
- Registration Number
- NCT04581551
- Lead Sponsor
- University Hospital, Ghent
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stroke group Stretch intervention 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 Healthy controls SWE assessor 1 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 Stroke group No stretch intervention 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 Stroke group SWE assessor 1 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 Stroke group SWE assessor 2 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
- Primary Outcome Measures
Name Time Method SWV m. infraspinatus Single point of assessment on day 2 (retest) Shear wave velocity of the m. infraspinatus
SWV m. pectoralis major Single point of assessment on day 2 (retest) Shear wave velocity of the m. pectoralis major
SWV m. supraspinatus Single point of assessment on day 2 (retest) Shear wave velocity of the m. supraspinatus
SWV m. deltoideus Single point of assessment on day 2 (retest) Shear wave velocity of the m. deltoideus
SWV m. pectoralis minor Single point of assessment on day 2 (retest) Shear wave velocity of the m. pectoralis minor
SWV m. rhomboideus major Single point of assessment on day 2 (retest) Shear wave velocity of the m. rhomboideus major
- Secondary Outcome Measures
Name Time Method Sports before stroke Assessment day 1 Question if stroke patients performed sports before stroke and which sports they performed before stroke
Passive range of motion of shoulder Baseline assessment day 1 Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)
Spasticity shoulder muscles Assessment day 1 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 Assessment day 1 Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted
Subjective feeling of shoulder stiffness Assessment day 1 Question to the patients about how stiff the shoulder feels
Demographic variables Baseline assessment day 1 Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis
Fugl-Meyer assessment upper limb section Assessment day 1 Active recovery of the upper limb motor function
Trial Locations
- Locations (2)
Ghent University
🇧🇪Ghent, Belgium
Ghent University Hospital
🇧🇪Ghent, Belgium