Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:40 AM
Study NCT ID:
NCT07314918
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structural Remodeling of Tibialis Anterior Muscle in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pennation Angle', 'timeFrame': 'at baseline assessment', 'description': 'The Pennation Angle is the angle formed between muscle fascicles and the deep aponeurosis, serving as a critical determinant of muscle force-generating capacity. Measured via longitudinal ultrasonography on the Tibialis Anterior, this parameter quantifies structural remodeling. In stroke survivors, alterations in this angle reflect muscle atrophy and directly impact functional recovery and gait potential.'}, {'measure': 'Muscle Thickness', 'timeFrame': 'at baseline assessment', 'description': 'Muscle Thickness is defined as the perpendicular distance between the superficial and deep aponeuroses at the widest point of the muscle belly. Measured via ultrasonography on the Tibialis Anterior, it serves as a direct indicator of muscle volume. In stroke survivors, reduced thickness quantifies the extent of muscle atrophy, providing insight into the loss of contractile mass and associated weakness.'}, {'measure': 'Muscle Fascicle Length', 'timeFrame': 'at baseline assessment', 'description': 'Muscle Fascicle Length is defined as the linear distance between the superficial and deep aponeuroses along the muscle fiber path. Assessed via ultrasonography in the Tibialis Anterior, this parameter is a key determinant of muscle shortening velocity and excursion range. In post-stroke patients, shortened fascicles often indicate structural adaptations related to spasticity and reduced functional mobility.'}], 'secondaryOutcomes': [{'measure': 'The Brunnstrom Recovery Stage', 'timeFrame': 'at baseline assessment', 'description': 'The Brunnstrom Recovery Stage is a standardized clinical tool used to evaluate motor recovery in stroke survivors. It classifies the progression of motor function into six sequential stages, ranging from flaccidity (Stage 1) to isolated, near-normal movement (Stage 6). In this study, it quantifies lower extremity motor impairment to correlate functional recovery status with the structural architectural changes observed in the Tibialis Anterior muscle.'}, {'measure': 'The Functional Ambulation Scale (FAS)', 'timeFrame': 'at baseline assessment', 'description': 'The Functional Ambulation Scale (FAS) is a clinical instrument used to categorize gait ability based on the level of physical assistance required by the patient. Classifications range from 0 (non-functional) to 5 (independent). In this study, FAS is utilized to quantify walking dependence, facilitating the analysis of the relationship between functional mobility levels and the structural remodeling of the Tibialis Anterior muscle.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography', 'Stroke', 'Muscle Architecture', 'Pennation Angle', 'Fascicle Length', 'Muscle Thickness'], 'conditions': ['Stroke', 'Tibialis Anterior Architecture']}, 'referencesModule': {'references': [{'pmid': '21945568', 'type': 'RESULT', 'citation': 'Ramsay JW, Barrance PJ, Buchanan TS, Higginson JS. Paretic muscle atrophy and non-contractile tissue content in individual muscles of the post-stroke lower extremity. J Biomech. 2011 Nov 10;44(16):2741-6. doi: 10.1016/j.jbiomech.2011.09.001. Epub 2011 Sep 25.'}, {'pmid': '11210948', 'type': 'RESULT', 'citation': 'Lieber RL, Friden J. Clinical significance of skeletal muscle architecture. Clin Orthop Relat Res. 2001 Feb;(383):140-51. doi: 10.1097/00003086-200102000-00016.'}, {'pmid': '15153151', 'type': 'RESULT', 'citation': 'Kottink AI, Oostendorp LJ, Buurke JH, Nene AV, Hermens HJ, IJzerman MJ. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Artif Organs. 2004 Jun;28(6):577-86. doi: 10.1111/j.1525-1594.2004.07310.x.'}, {'pmid': '21571152', 'type': 'RESULT', 'citation': 'Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.'}, {'pmid': '25133011', 'type': 'RESULT', 'citation': 'Ramsay JW, Wessel MA, Buchanan TS, Higginson JS. Poststroke muscle architectural parameters of the tibialis anterior and the potential implications for rehabilitation of foot drop. Stroke Res Treat. 2014;2014:948475. doi: 10.1155/2014/948475. Epub 2014 Jul 16.'}]}, 'descriptionModule': {'briefSummary': "This study aims to investigate the structural architectural changes of the Tibialis Anterior muscle in patients with subacute and chronic stroke using ultrasonography. The study will compare the morphological parameters (pennation angle, fascicle length, and muscle thickness) of the paretic side with the non-paretic side and analyze the relationship between these structural changes and the patients' clinical and demographic data.", 'detailedDescription': "Stroke is a serious neurological disease characterized by high mortality, morbidity, and disability rates. Post-stroke motor and sensory impairments significantly limit patients' independence. A common impairment is hemiparesis, specifically weakness in the paretic leg leading to reduced dorsiflexion range of motion (foot drop). It remains unclear whether this weakness stems solely from neurological impairment or also involves changes in muscle architecture. Muscle fascicle length and pennation angle are critical architectural parameters influencing force production capacity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This group consists of patients in the subacute and chronic phase post-stroke who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients aged 40-80 years.\n* History of ischemic or hemorrhagic Cerebrovascular Accident (CVA).\n* Being in the subacute or chronic phase post-stroke.\n* Absence of communication deficits; ability to follow verbal commands.\n* Voluntary agreement to participate and provision of written informed consent.\n* Ability to ambulate without physical assistance from another person (use of assistive devices such as leg orthoses or tripods is permitted).\n\nExclusion Criteria:\n\n* Presence of other comorbidities affecting gait (e.g., Parkinson's disease, hip surgery, etc.).\n* History of dyspnea (shortness of breath) during activities of daily living within the last 6 months.\n* Presence of bone or joint-related pain or pathology in the spine or hips.\n* Presence of psychiatric or cognitive disorders (e.g., learning disabilities, mental disorders, autism, etc.).\n* Decompensated cardiac, renal, or hepatic failure.\n* Presence of malignancy."}, 'identificationModule': {'nctId': 'NCT07314918', 'briefTitle': 'Structural Remodeling of Tibialis Anterior Muscle in Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Structural Remodeling of the Tibialis Anterior Muscle in Subacute and Chronic Stroke: A Clinical Correlation Study', 'orgStudyIdInfo': {'id': 'IstPRMTRH-EK5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subacute Stroke Patients', 'description': 'This group consists of patients in the subacute phase post-stroke (1 week to 6 months) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital. Ultrasonographic assessment will be performed to determine the structural characteristics of the Tibialis anterior muscle. Measurements will be taken from the mid-belly region where muscle thickness is maximal. The patient will be in a supine position at rest, with the ankle in a neutral position on a stable surface. Pennation angle, muscle fascicle length, and muscle thickness will be measured. Measurements will be repeated three times, and the arithmetic mean of these three measurements will be calculated.'}, {'label': 'Chronic Stroke Patients', 'description': 'This group consists of patients in the chronic phase post-stroke ( \\> 6 months) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.\n\nUltrasonographic assessment will be performed to determine the structural characteristics of the Tibialis anterior muscle. Measurements will be taken from the mid-belly region where muscle thickness is maximal. The patient will be in a supine position at rest, with the ankle in a neutral position on a stable surface. Pennation angle, muscle fascicle length, and muscle thickness will be measured. Measurements will be repeated three times, and the arithmetic mean of these three measurements will be calculated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34186', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Eser Kalaoğlu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 6 months and ending 1 year following article publication.', 'ipdSharing': 'YES', 'description': "De-identified individual participant data (IPD), including all demographic, clinical, and primary/secondary outcome measures will be shared with qualified researchers. The sharing period will commence 6 months after article publication and conclude 1 year thereafter. Data access requests must be accompanied by a methodologically sound proposal and will be granted upon the corresponding author's approval and the execution of a Data Use Agreement (DUA) to strictly ensure confidentiality and adherence to ethical guidelines.", 'accessCriteria': 'Qualified researchers who present a methodologically robust proposal aimed at fulfilling the objectives of the approved project.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eser Kalaoglu', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}