Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT04581551
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2020-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subcutaneous tissue thickness', 'timeFrame': 'Single point of assessment on day 1', 'description': 'Measurement de thickness of the subcutaneous layer on the ultrasound image of the m. pectoralis major to compare the stroke group and healthy control group.'}], 'primaryOutcomes': [{'measure': 'SWV m. supraspinatus', 'timeFrame': 'Single point of assessment on day 1 (test)', 'description': 'Shear wave velocity of the m. supraspinatus'}, {'measure': 'SWV m. supraspinatus', 'timeFrame': 'Single point of assessment on day 2 (retest)', 'description': 'Shear wave velocity of the m. supraspinatus'}, {'measure': 'SWV m. infraspinatus', 'timeFrame': 'Single point of assessment on day 1 (test)', 'description': 'Shear wave velocity of the m. infraspinatus'}, {'measure': 'SWV m. infraspinatus', 'timeFrame': 'Single point of assessment on day 2 (retest)', 'description': 'Shear wave velocity of the m. infraspinatus'}, {'measure': 'SWV m. rhomboideus major', 'timeFrame': 'Single point of assessment on day 1 (test)', 'description': 'Shear wave velocity of the m. rhomboideus major'}, {'measure': 'SWV m. rhomboideus major', 'timeFrame': 'Single point of assessment on day 2 (retest)', 'description': 'Shear wave velocity of the m. rhomboideus major'}, {'measure': 'SWV m. deltoideus', 'timeFrame': 'Single point of assessment on day 1 (test)', 'description': 'Shear wave velocity of the m. deltoideus'}, {'measure': 'SWV m. deltoideus', 'timeFrame': 'Single point of assessment on day 2 (retest)', 'description': 'Shear wave velocity of the m. deltoideus'}, {'measure': 'SWV m. pectoralis major', 'timeFrame': 'Single point of assessment on day 1 (test)', 'description': 'Shear wave velocity of the m. pectoralis major'}, {'measure': 'SWV m. pectoralis major', 'timeFrame': 'Single point of assessment on day 2 (retest)', 'description': 'Shear wave velocity of the m. pectoralis major'}, {'measure': 'SWV m. pectoralis minor', 'timeFrame': 'Single point of assessment on day 1 (test)', 'description': 'Shear wave velocity of the m. pectoralis minor'}, {'measure': 'SWV m. pectoralis minor', 'timeFrame': 'Single point of assessment on day 2 (retest)', 'description': 'Shear wave velocity of the m. pectoralis minor'}], 'secondaryOutcomes': [{'measure': 'Demographic variables', 'timeFrame': 'Baseline assessment day 1', 'description': 'Age, gender, weight, height, dominance, date of birth, stroke date, type of stroke, side of paresis'}, {'measure': 'Passive range of motion of shoulder', 'timeFrame': 'Baseline assessment day 1', 'description': 'Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation (degrees)'}, {'measure': 'Spasticity shoulder muscles', 'timeFrame': 'Assessment day 1', 'description': 'Modified Ashworth Scale (minimum 0 - maximum 4, higher score is more spasticity = worse outcome) of shoulder flexors, extensors, internal rotators, external rotators, adductors, abductors'}, {'measure': 'Shoulder subluxation - ultrasound measurement', 'timeFrame': 'Assessment day 1', 'description': 'Acromiohumeral distance of the hemiplegic and non-hemiplegic shoulder subtracted'}, {'measure': 'Fugl-Meyer assessment upper limb section', 'timeFrame': 'Assessment day 1', 'description': 'Active recovery of the upper limb motor function'}, {'measure': 'Subjective feeling of shoulder stiffness', 'timeFrame': 'Assessment day 1', 'description': 'Question to the patients about how stiff the shoulder feels'}, {'measure': 'Sports before stroke', 'timeFrame': 'Assessment day 1', 'description': 'Question if stroke patients performed sports before stroke and which sports they performed before stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Shear wave elastography', 'Shoulder muscles', 'Shoulder pain'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study aims\n\n1. To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke.\n2. 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).\n3. 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).', 'detailedDescription': 'Stroke patients will be assessed on 2 days with an interval of 3 days (Friday - Monday).\n\nDay 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).\n\nAt the end of the assessment secondary outcome measures will be assessed.\n\nDay 2 (Monday): SWV will be reassessed by assessor 1 to measure test-retest reliability.\n\nPosition of the patient will be changed. SWV of the pectoralis major and minor muscle will be reassessed.\n\nAssessor 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.\n\nHealthy controls (matched for age, gender and BMI):\n\nOnly one test day to assess SWV of 6 shoulder muscles. Secondary outcome measures will be assessed after SWE assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Stroke group\n\nInclusion:\n\n* Stroke patients in the subacute phase after stroke (\\< 6 months post stroke)\n* Able to sit independently with support of the back, but without support of the arms\n* With upper-limb (UL) impairment: i.e. no maximum score (36) on the shoulder elbow part of the Fugl-Meyer UL (FM UL)\n\nExclusion Criteria:\n\n* Other neurologic disorders\n* Shoulder or neck surgery before stroke onset\n* Arthroscopic surgery in the last year before stroke onset.\n* Shoulder or neck pain in the last year before stroke onset.\n* 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.\n* Participants who are not able to maintain the test position.\n* Pregnancy\n\nHealthy controls can participate if they\n\n* Have not suffered a stroke or other neurological disorders\n* Did not have surgery at the shoulder and/or neck\n* Did not have arthroscopic surgery in the last year before stroke\n* If they do not suffer any shoulder or neck pain'}, 'identificationModule': {'nctId': 'NCT04581551', 'acronym': 'SWE_stroke', 'briefTitle': 'Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Reliability and Validity Study to Assess the Test-retest and Intra-rater Reliability of SWE in Shoulder Muscles in Persons After Stroke.', 'orgStudyIdInfo': {'id': 'B6702020000601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stroke group', 'description': 'SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order.\n\n* m. supraspinatus\n* m. infraspinatus\n* m. rhomboideus major\n* m. deltoideus\n* m. pectoralis major\n* m. pectoralis minor', 'interventionNames': ['Procedure: SWE assessor 1', 'Procedure: SWE assessor 2', 'Procedure: Stretch intervention', 'Procedure: No stretch intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'SWE for 6 shoulder muscles will be performed by 1 assessors.\n\n* m. supraspinatus\n* m. infraspinatus\n* m. rhomboideus major\n* m. deltoideus\n* m. pectoralis major\n* m. pectoralis minor', 'interventionNames': ['Procedure: SWE assessor 1']}], 'interventions': [{'name': 'SWE assessor 1', 'type': 'PROCEDURE', 'description': 'SWE for 6 shoulder muscles will be performed.\n\n* m. supraspinatus\n* m. infraspinatus\n* m. rhomboideus major\n* m. deltoideus\n* m. pectoralis major\n* m. pectoralis minor', 'armGroupLabels': ['Healthy controls', 'Stroke group']}, {'name': 'SWE assessor 2', 'type': 'PROCEDURE', 'description': 'SWE for 6 shoulder muscles will be performed.\n\n* m. supraspinatus\n* m. infraspinatus\n* m. rhomboideus major\n* m. deltoideus\n* m. pectoralis major\n* m. pectoralis minor', 'armGroupLabels': ['Stroke group']}, {'name': 'Stretch intervention', 'type': 'PROCEDURE', 'description': 'Transversal stretch of pectoralis major muscle on the hemiplegic side.', 'armGroupLabels': ['Stroke group']}, {'name': 'No stretch intervention', 'type': 'PROCEDURE', 'description': 'Passive mobilisation of the hemiplegic hand.', 'armGroupLabels': ['Stroke group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Annelies Maenhout, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}, {'name': 'Kristine Oostra, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}, {'name': 'Dirk Cambier, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}