Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-05 @ 2:01 PM
Study NCT ID:
NCT06682702
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Dynamic Neuromuscular Stabilization Breathing Exercises With Schroth in Adolescent Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Model description training and control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-11-08', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cobb Angel', 'timeFrame': '8 weeks', 'description': 'The Cobb angle will be measured using standing full-spine X-rays to quantify the degree of spinal curvature in patients with scoliosis.'}, {'measure': 'Respiratory Muscle Strength', 'timeFrame': '8 weeks', 'description': 'Respiratory muscle strength was measured using an electronic mouth pressure measuring device (Cosmed Ponyy Fx, Rome, Italy). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) were measured.'}, {'measure': 'Angle Trunk Rotation', 'timeFrame': '8 weeks', 'description': 'The Adams forward bending test, commonly used in scoliosis screening, involves positioning the patient with arms extended forward to assess for asymmetric protrusions and coronal imbalance in the back, while a scoliometer is utilized to measure the degree of spinal rotation and track progression of trunk asymmetry and deformity.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '8 weeks', 'description': "The Visual Analog Scale (VAS) will be used to measure pain intensity by having participants mark their perceived level of pain on a 10-centimeter line ranging from 'no pain' to 'worst pain imaginable."}, {'measure': 'Scoliosis Research Society-22 (SRS-22) Quality of Life Questionnaire', 'timeFrame': '8 weeks', 'description': "The Scoliosis Research Society-22 (SRS-22) Quality of Life Questionnaire measures the impact of scoliosis on patients' quality of life across five domains: function, pain, self-image, mental health, and satisfaction, using a total of 22 questions."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'surgery', 'therapy', 'Rehabilitation Exercise', 'Exercise Therapy'], 'conditions': ['Adolescent Idiopathic Scoliosis (AIS)']}, 'descriptionModule': {'briefSummary': 'In our study, the degree of scoliosis curvature in volunteers will be determined using full-body standing X-rays. Additionally, the rotation degree of the spinal curvature in volunteers will be assessed with a scoliosis meter (a type of ruler) through the forward bending test while standing. To measure the impact of scoliosis on the quality of life, the SRS-22 questionnaire, consisting of 22 questions, will be used. The level of pain experienced by volunteers as a result of scoliosis will be evaluated using the visual analog scale (VAS), where pain intensity is marked on a 10 centimeter line. Lastly, the volunteers; breathing patterns will be assessed by measuring chest circumference with a tape measure.', 'detailedDescription': 'In this randomized controlled trial, we aim to assess various physical and quality of life parameters in volunteers with scoliosis. The degree of spinal curvature will be measured using full body standing X-rays, providing a detailed assessment of the scoliosis angle. Additionally, the rotation degree of the spinal curvature will be evaluated with a scoliosis meter during the forward bending test, which is commonly used to gauge the rotational component of scoliosis.\n\nQuality of life will be assessed using the Scoliosis Research Society-22 (SRS-22) questionnaire, a validated tool consisting of 22 questions designed to evaluate function, pain, self image, mental health, and satisfaction in individuals with scoliosis. To quantify pain levels experienced due to scoliosis, the Visual Analog Scale (VAS) will be used, in which participants mark their pain intensity on a 10 centimeter line, ranging from "no pain" to "worst pain imaginable." This provides an accurate, subjective measure of pain severity.\n\nBreathing patterns will also be evaluated by measuring the volunteers\' chest circumference at full inspiration and expiration using a standard tape measure, allowing us to assess any potential restrictions in lung expansion related to the spinal curvature. Through this comprehensive evaluation, we hope to gain a clearer understanding of how scoliosis affects both the physical and psychological well being of individuals and identify potential areas for therapeutic intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiologically measured Cobb angle value between 10 degrees and 50 degrees\n* Age between 10 and 18\n* Being diagnosed with Adolescent Idiopathic Scoliosis by a physician\n* Being between 0 and 5 in the radiologically determined Risser sign\n* Being between 12-25 kg/m2 according to body mass index measurement\n\nExclusion Criteria:\n\n* Having had any surgery related to scoliosis\n* Having been diagnosed with any psychiatric disease\n* Having been diagnosed with an oncological disease\n* Having a neurological disease, vestibular or visual problem\n* Having any pathology that will affect motor performance\n* Using medication that affects the central nervous system\n* Having been diagnosed with a rheumatological disease\n* Having been diagnosed with any cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT06682702', 'briefTitle': 'Effectiveness of Dynamic Neuromuscular Stabilization Breathing Exercises With Schroth in Adolescent Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'The Effectiveness of Dynamic Neuromuscular Stabilization Breathing Exercises in Addition to Schroth Exercises in Individuals With Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '2024-PT-MRVB-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DNS Group', 'description': 'Patients diagnosed with adolescent idiopathic scoliosis participated in sessions twice a week for 8 weeks, with each session lasting 45 minutes. During the sessions, ISST Schroth exercises were combined with dynamic neuromuscular stabilization exercises.', 'interventionNames': ['Other: DNS Group']}, {'type': 'EXPERIMENTAL', 'label': 'Schroth Group', 'description': 'Patients diagnosed with adolescent idiopathic scoliosis participated in sessions twice a week for 8 weeks, with each session lasting 45 minutes. During the sessions, ISST Schroth exercises were performed.', 'interventionNames': ['Other: Schroth Group']}], 'interventions': [{'name': 'DNS Group', 'type': 'OTHER', 'otherNames': ['Schroth Exercise', 'Dynamic Neuromuscular Stabilization'], 'description': 'ISST Schroth exercises are a model of exercise aimed at correcting scoliosis in three dimensions. Dynamic neuromuscular stabilization exercises, on the other hand, are designed to achieve sagittal stabilization by utilizing the stabilizing function of the thoracic diaphragm muscle.', 'armGroupLabels': ['DNS Group']}, {'name': 'Schroth Group', 'type': 'OTHER', 'otherNames': ['Schroth Exercise'], 'description': 'ISST Schroth exercises are a model of exercise aimed at correcting scoliosis in three dimensions.', 'armGroupLabels': ['Schroth Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'MERVE BASARDI', 'role': 'CONTACT', 'email': 'mervebasardi@st.uskudar.edu.tr', 'phone': '+90(531)3797303'}], 'facility': 'Uskudar University Physiotherapy and Rehabilitation Application and Research Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Merve Basardi, PT.', 'role': 'CONTACT', 'email': 'mervebasardi@st.uskudar.edu.tr', 'phone': '+905313797303'}], 'overallOfficials': [{'name': 'Filiz Eyuboglu, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uskudar University'}, {'name': 'Mert Ilhan, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'MERVE BAŞARDI', 'investigatorAffiliation': 'Uskudar University'}}}}