Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 10:59 AM
Study NCT ID:
NCT06320561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscular Changes in the First 12 Weeks After Stroke.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Ambulation Categories (FAC)-score', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Scores ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface)'}, {'measure': 'Muscle volume', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Cross-sectional area (CSA)', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Physiological cross-sectional area (pCSA)', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Muscle tickness', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Fascicle length', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Muscle length', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Tendon length', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 3D freehand ultrasound (3DfUS)'}, {'measure': 'Pennation angle', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 2D ultrasound'}, {'measure': 'Echo Intensity', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through 2D ultrasound'}, {'measure': 'Dynamic muscle morphology', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Dynamic 2D ultrasound used to investigate the changes in cross-sectional area (CSA) en fascicle length'}, {'measure': 'Change in cross-sectional area', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through dynamic 2D ultrasound'}, {'measure': 'Change in fascicle length', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through dynamic 2D ultrasound'}, {'measure': 'Average root mean square (RMS)', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through surface electromyography (sEMG)'}, {'measure': 'Peak root mean square (RMS)', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Through surface electromyography (sEMG)'}, {'measure': 'Muscle strength', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke', 'description': 'Assessed with a handheld dynamometer (Nm)'}, {'measure': 'Spasticity', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke.', 'description': 'Assessed with the Tardieu Scale. Scores ranging from 0 (no resistance throughout passive movement) to 5 (immobile joint).'}, {'measure': 'Lower limb motor impairment', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke.', 'description': 'Fugl-Meyer Assessment of the lower limb (FMA LL). Scores ranging from 0 to 34 (no impairment present).'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'Frequency: week 1, 5, 8 and 12 after stroke.', 'description': 'Patients will perform the 10-meter walk test while wearing the GaitUp sensors.'}, {'measure': 'Gait quality', 'timeFrame': 'Frequency: only at week 12.', 'description': "Gait profile score (index number in degrees (°)), calculated from the lower limbs' kinematics (3D gait analysis). A higher score means more deviation of the expected (normal) gait pattern."}], 'secondaryOutcomes': [{'measure': 'TWIST-score', 'timeFrame': 'Within first week after stroke', 'description': 'TWIST gait prediction model scores will be calculated to externally validate this model.'}, {'measure': 'Knee extension strength', 'timeFrame': 'Frequency: only during the first assessment (week 1).', 'description': 'Medical Research Council knee extension. Scores ranging from 0 (no muscular activity) to 5 (normal strength).'}, {'measure': 'Balance', 'timeFrame': 'Frequency: only during the first assessment (week 1)', 'description': 'Berg Balance Scale. Scores ranging from 0 (Severe balance deficits) to 56 (normal balance).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscular changes', 'm. rectus femoris', 'm. gastrocnemius medials', 'Lower limb impairment', 'Gait recovery', 'Subacute phase', '3DfUS', 'sEMG', 'Dynamic ultrasound'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '35586876', 'type': 'BACKGROUND', 'citation': 'Smith MC, Barber AP, Scrivener BJ, Stinear CM. The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. Neurorehabil Neural Repair. 2022 Jul;36(7):461-471. doi: 10.1177/15459683221085287. Epub 2022 May 18.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery.', 'detailedDescription': 'During this longitudinal study, patients who suffer their first-ever stroke will be included within the first week after their stroke (if the inclusion criteria are met). Thereafter, each participant will be assessed at four pre-determined time-points: week 1, 5, 8 and 12 after stroke.\n\nOn each of the four time-points, the investigators will assess muscle specific parameters of the affected m. rectus femoris (RF) and m. gastrocnemius medialis (GM), together with clinical tests to assess lower limb impairment (Fugl-Meyer Assessment for the lower limb and the Tardieu scale) and gait parameters (10-meter walk test). Specifically, muscle specific parameters will be investigated using 3D freehand ultrasound (3DfUS) and combined dynamic 2D US and surface electromyography (sEMG). Such assessments will help us characterize the electromechanical properties of these muscles, their time-related trajectories and the relationship with the recovery of gait and lower limb function after stroke. At the end of the investigation period, after 3 months, patients who can walk independently will perform a 3D gait analysis. As such, the relationship between changes in muscle specific parameters and the eventual gait quality at the end of the investigation period will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons who suffer their first-ever stroke (ischaemic or hemorrhagic) will be investigated during the subacute phase after the stroke (i.e. first 3 months).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥ 18 years old)\n* Diagnosed with a first-ever stroke (as defined by WHO)\n* Stroke onset ≤ 1 week (± 3 days)\n* Able to provide written or verbal informed consent at admission\n* Presence of gait problems as a consequence of the stroke (FAC≤4)\n\nExclusion Criteria:\n\n* Presence of other neurological or orthopedic problems present prior to, or not caused as a direct consequence of, the stroke leading to impaired gait.\n* Modified Ranking scale pre-stroke \\> 1/6, meaning presence of slight disability before the stroke.\n* Presence of severe comorbidities (e.g. osteoporosis, cardiovascular instability or chronic obstructive pulmonary disease).\n* Cerebellar or bilateral stroke.\n* Presence of severe deficits in communication, memory or understanding precluding informed consent.'}, 'identificationModule': {'nctId': 'NCT06320561', 'acronym': 'StrIMuC12', 'briefTitle': 'Muscular Changes in the First 12 Weeks After Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Stroke-induced Muscular Changes and Their Relation to Clinical Impairments and Gait Recovery in the First 12 Weeks After Stroke.', 'orgStudyIdInfo': {'id': '23485_StrIMuC12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients in the first 3 months after stroke', 'description': 'Inclusion criteria:\n\nAdults (≥ 18 years old) Diagnosed with a first-ever stroke (as defined by WHO) Stroke onset ≤ 1 week (± 3 days) Able to provide written or verbal informed consent at admission Presence of gait problems as a consequence of the stroke (FAC≤4)\n\nExclusion criteria:\n\nPresence of other neurological or orthopedic problems present prior to, or not caused as a direct consequence of, the stroke leading to impaired gait.\n\nModified Ranking scale pre-stroke \\> 1/6, meaning presence of slight disability before the stroke.\n\nPresence of severe comorbidities (e.g. osteoporosis, cardiovascular instability or chronic obstructive pulmonary disease).\n\nCerebellar or bilateral stroke. Presence of severe deficits in communication, memory or understanding precluding informed consent.', 'interventionNames': ['Other: Longitudinal prospective cohort study']}], 'interventions': [{'name': 'Longitudinal prospective cohort study', 'type': 'OTHER', 'description': 'Patients after stroke who meet the in- and exclusion criteria will be examined 4 times during the first 3 months after their stroke.', 'armGroupLabels': ['Patients in the first 3 months after stroke']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Daan De Vlieger, Msc.', 'role': 'CONTACT', 'email': 'daan.de.vlieger@vub.be', 'phone': '+32 (0)2 477 44 89'}], 'overallOfficials': [{'name': 'Eva Swinnen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'Research Foundation Flanders', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Eva Swinnen', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}