Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:55 PM
Study NCT ID:
NCT07447804
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Baseline assessment at a single time point.', 'description': 'The MMSE, developed by Folstein et al. in 1975, is a widely used, valid, and reliable test for assessing cognitive impairment. The MMSE is a 30-point, multi-item scale that evaluates five domains: orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points), and language (9 points). In 2002, Güngen et al. demonstrated that the Turkish version of the MMSE is valid and reliable.'}, {'measure': 'Respiratory Muscle Strength (MIP)', 'timeFrame': 'Baseline assessment at a single time point.', 'description': 'Respiratory muscle strength will be measured using an electronic, portable intraoral pressure device (MicroRPM, Micro Medical; United Kingdom). All measurements will be performed in the seated position. The nasal airway will be occluded using a nose clip, and an appropriate mouthpiece will be used.\n\nFor MIP assessment, the patient will first perform a maximal expiration before placing the device in the mouth, followed by a maximal inspiratory effort (Müller maneuver) at maximum speed sustained for 1-3 seconds.\n\nThis maneuver will be repeated three times, and the highest value will be recorded in cmH₂O.'}, {'measure': 'Respiratory Muscle Strength (MEP)', 'timeFrame': 'Baseline assessment at a single time point.', 'description': 'Respiratory muscle strength will be measured using an electronic, portable intraoral pressure device (MicroRPM, Micro Medical; United Kingdom). All measurements will be performed in the seated position. The nasal airway will be occluded using a nose clip, and an appropriate mouthpiece will be used.\n\nFor MEP assessment, the patient will first perform a maximal inspiration before placing the device in the mouth, followed by a maximal expiratory effort (Valsalva maneuver) at maximum speed sustained for 1-3 seconds.\n\nThis maneuver will be repeated three times, and the highest value will be recorded in cmH₂O.'}, {'measure': 'Diaphragmatic Ultrasonography', 'timeFrame': 'Baseline assessment at a single time point.', 'description': 'Diaphragm excursion will be assessed using M-mode ultrasonography, and diaphragm thickness and contractility will be measured using B-mode ultrasonography.\n\nPatients will be evaluated in the supine position. Diaphragm thickness will be measured at end-expiration from the 9th intercostal space along the anterior axillary line using a 7-MHz linear transducer. Diaphragm motion during normal and deep breathing will be assessed with a 3.5-MHz curved transducer from the right hemidiaphragm.\n\nThe difference between inspiratory and expiratory measurements will be analyzed, and diaphragm thickening fraction will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Diaphragm', 'Ultrasonography', 'Pulmonary Funtion', 'Subacute Hemiplegia', 'Diaphragm morphology', 'Respiratory muscle strength', 'Rehabilitation'], 'conditions': ['Stroke', 'Hemiplegia Following Ischemic Stroke', 'Diaphragm Ultrasonography']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the relationship between diaphragm morphology (diaphragm excursion, end-inspiratory and end-expiratory diaphragm thickness, and thickening fraction) and respiratory muscle strength (maximum inspiratory pressure - MIP and maximum expiratory pressure - MEP) in patients with subacute hemiplegia.', 'detailedDescription': 'Stroke is a neurological condition that causes multidimensional impairments in motor, sensory, and pulmonary functions and is associated with a high long-term disability burden. After stroke, weakness particularly develops in the diaphragm and intercostal muscles; this results in reduced chest wall movements, ventilatory restriction, and decreased lung volumes. The diaphragm, the primary inspiratory muscle, being positioned higher on the paretic side and exhibiting reduced movement leads to decreased respiratory capacity and impaired cough effectiveness.\n\nDiaphragm ultrasonography is a method that allows noninvasive, reliable, and reproducible evaluation of diaphragm thickness, excursion, and functional changes. The relationship between ultrasound parameters and respiratory muscle strength is of clinical importance in determining the degree of respiratory muscle weakness and setting rehabilitation goals.\n\nAlthough it is known that post-stroke MIP and MEP values are significantly reduced compared to healthy individuals, the relationship between diaphragm morphology and respiratory muscle strength has been investigated to a limited extent, particularly in the subacute period. Demonstrating this relationship will make an important contribution to planning individualized respiratory rehabilitation in the early period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subacute ischemic hemiplegia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-80 years\n* Clinical diagnosis of hemiplegia\n* Subacute phase (1-6 months post-onset)\n* Ability to tolerate diaphragm ultrasonography and MIP/MEP measurements\n* MMSE score ≥ 24\n* Adequate level of consciousness and ability to cooperate\n\nExclusion Criteria:\n\n* Respiratory comorbidities such as COPD, asthma, or interstitial lung disease\n* Diaphragmatic paralysis or severe chest wall deformity\n* Acute cardiopulmonary conditions preventing respiratory function testing\n* Severe cognitive impairment that may affect measurements\n* Inability to perform ultrasound assessment due to prior gastric or abdominal surgery'}, 'identificationModule': {'nctId': 'NCT07447804', 'briefTitle': 'Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fenerbahce University'}, 'officialTitle': 'The Relationship Between Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'FenerbahceUniversity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subacute Hemiplegia Patients', 'description': 'Patients with subacute hemiplegia following stroke will be evaluated. Diaphragm morphology (diaphragm excursion, end-inspiratory and end-expiratory diaphragm thickness, and thickening fraction) will be assessed using ultrasonography. Respiratory muscle strength will be measured by maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). No intervention will be applied. This is an observational study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Istanbul', 'state': 'Ataşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sümeyye Akçay, Asst. Prof.', 'role': 'CONTACT', 'email': 'smyye.akcy@gmail.com', 'phone': '+905424002553'}], 'facility': 'Fenerbahçe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Sümeyye Akçay, Asst. Prof.', 'role': 'CONTACT', 'email': 'smyye.akcy@gmail.com', 'phone': '+905424002553'}], 'overallOfficials': [{'name': 'Sümeyye Akçay, Asst. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fenerbahçe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fenerbahce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Sümeyye Akçay', 'investigatorAffiliation': 'Fenerbahce University'}}}}