Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT06884150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Control Group (healthy participants) Group 2: Scoliosis group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fNIRs device', 'timeFrame': 'Between 3th month-9th month', 'description': 'After the installation and testing of the FNIRS device, recording and analysis are performed.'}, {'measure': 'Y-balance test', 'timeFrame': 'Between 3th month-9th month', 'description': 'Determination of maximum percentage reach and combined score from the Y-balance test,'}], 'secondaryOutcomes': [{'measure': 'Scoliosis Research Society-22 (SRS-22)', 'timeFrame': 'Between 3th month-9th month', 'description': 'Quality of life scale is determined with 5 sub-scores and a total score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fNIRS'], 'conditions': ['Scoliosis Idiopathic', 'Scoliosis; Adolescence']}, 'referencesModule': {'references': [{'pmid': '31082657', 'type': 'BACKGROUND', 'citation': 'Surgent OJ, Dadalko OI, Pickett KA, Travers BG. Balance and the brain: A review of structural brain correlates of postural balance and balance training in humans. Gait Posture. 2019 Jun;71:245-252. doi: 10.1016/j.gaitpost.2019.05.011. Epub 2019 May 6.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31082657/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of Schroth-based rehabilitation on cortical dynamics, body awareness, and quality of life in individuals with Adolescent Idiopathic Scoliosis (AIS). Using fNIRS technology, motor control processes will be monitored, and the impact of rehabilitation on brain activity will be assessed.\n\nA total of 30 participants (15 healthy and 15 with AIS), aged 8-16, will be examined, with pre- and post-rehabilitation comparisons. Measurements will include static posture, Y-Balance Test, Schroth walking, and brain activity recordings. SPM analysis will be used to assess brain signals, and quality of life and cosmetic deformity perception will be statistically evaluated.\n\nThe findings will contribute to the integration of neuroimaging into rehabilitation assessment, helping to develop more effective treatment strategies.', 'detailedDescription': "The evaluation of body schema and perception in the cortex of adolescent idiopathic scoliosis and the analysis of changes in brain regions functionally related to motor control and coordination between controls and the analysis of their developmental process with rehabilitation are very important in terms of contributing to the planning of a better effective rehabilitation process, increasing the patient's quality of life and evaluating the status of body representation related to the disease, its development and sustainability in daily life.\n\nfNIRS-based postural control neuroimaging and analysis will provide pioneering information about body schema, postural balance, motor activation and their rehabilitation-oriented changes and brain plasticity, which will provide separate analysis of dynamic and static balance.\n\nThe changes created by body schema and perception in the cortex in individuals with AIS and the rehabilitation-oriented developmental process will be evaluated with functional near-infrared spectroscopy (fNIRS) solutions, specifically in motor control and coordination.\n\nAnother important deficiency in the literature is the evaluation of changes created by rehabilitation processes in the cortex. Thanks to neural plasticity, a system that tries to compensate for a dysfunction can be reorganized. Therefore, rehabilitation studies are also of great importance here. The observed significant lateralization and body schema changes may also be useful for creating personalized and targeted corrective postural exercises.\n\nThe portable fNIRS device is an effective neuroimaging and analysis method for monitoring motor control processes in cortical areas in subjects moving without any movement restrictions. Therefore, especially in terms of body representation, since performing measurements in a limited area where the patient's movement is not possible, such as fMRI, does not provide very accurate results, especially since the evaluation of the change process created by motor movements in the cortex does not yield very accurate results, cortical dynamics in AIS individuals will be evaluated with fNIRS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 8-20\n* Being diagnosed with adolescent idiopathic scoliosis,\n* Accepting voluntary participation in the study.\n\nExclusion Criteria:\n\n* History of tumor, vertebral malformation, trauma, epilepsy,\n* Having had spine or lower extremity surgery,\n* Having diagnosed psychiatric problems,\n* Having any disease that would prevent them from exercising,\n* Having rheumatic disease,\n* Having congenital deformity,\n* Being on another treatment for scoliosis during the study period,\n* Having received any conservative treatment for scoliosis or posture disorder in the last six months,\n* Having a body mass index over 25,'}, 'identificationModule': {'nctId': 'NCT06884150', 'briefTitle': 'fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)', 'orgStudyIdInfo': {'id': 'Akdeniz UniversityTombak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '15 participant, healthy'}, {'type': 'EXPERIMENTAL', 'label': 'Scoliosis group', 'description': '* Being between the ages of 8-16,\n* Being diagnosed with adolescent idiopathic scoliosis,', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Participating in schroth exercises for 45 minutes, 2 days a week after receiving the relevant diagnosis', 'armGroupLabels': ['Scoliosis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'Between 3th month-9th month', 'ipdSharing': 'YES', 'description': 'A consent form will be obtained from the individuals participating in the study or their parents.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Kadriye Tombak', 'investigatorAffiliation': 'Akdeniz University'}}}}