Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT07201103
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Augmented Reality-Based Exercise Training in Adolescents With Idiopathic Scoliosis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors were blinded to group allocation to reduce assessment bias. Participants and care providers were not blinded due to the nature of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly allocated to either the control group (conventional PSSE-Schroth) or the intervention group (AR-assisted PSSE-Schroth). Both groups received supervised exercise training over 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Awareness (ABC - Vücut Farkındalık Çizelgesi)', 'timeFrame': 'Baseline (T0) and 4 weeks after intervention (T4).', 'description': 'Body awareness will be assessed using the standardized Awareness-Body-Chart (ABC). Participants rate awareness of different body regions, and a total score is calculated. The outcome is the change in total ABC score from baseline (T0) to the end of intervention (T4, 4th week). A higher score indicates greater body awareness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scoliosis', 'Adolescent Idiopathic Scoliosis', 'AR-based Rehabilitation', 'Augmented Reality Exercise Training', 'Physiotherapeutic Scoliosis-Specific Exercises (PSSE)', 'Schroth Method', 'Exercise Adherence', 'Body Awareness', 'Trunk Appearance Perception'], 'conditions': ['Adolescent Idiopathic Scoliosis']}, 'referencesModule': {'references': [{'pmid': '39964686', 'type': 'BACKGROUND', 'citation': 'Yuan W, Shi W, Chen L, Liu D, Lin Y, Li Q, Lu J, Zhang H, Feng Q, Zhang H; Digital Care Study Group. Digital Physiotherapeutic Scoliosis-Specific Exercises for Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459929. doi: 10.1001/jamanetworkopen.2024.59929.'}, {'type': 'BACKGROUND', 'citation': 'Cavalcanti, V. C., Ferreira, M. I. d. S., Teichrieb, V., Barioni, R. R., Correia, W. F. M., Da Gama, A. E. F. 2019. "Usability and effects of text, image and audio feedback on exercise correction during augmented reality based motor rehabilitation", Computers & Graphics, 85, 100-10.'}, {'pmid': '33857180', 'type': 'BACKGROUND', 'citation': 'Kocaman H, Bek N, Kaya MH, Buyukturan B, Yetis M, Buyukturan O. The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial. PLoS One. 2021 Apr 15;16(4):e0249492. doi: 10.1371/journal.pone.0249492. eCollection 2021.'}, {'pmid': '38631273', 'type': 'BACKGROUND', 'citation': 'Buyukturan O, Kaya MH, Alkan H, Buyukturan B, Erbahceci F. Comparison of the efficacy of Schroth and Lyon exercise treatment techniques in adolescent idiopathic scoliosis: A randomized controlled, assessor and statistician blinded study. Musculoskelet Sci Pract. 2024 Aug;72:102952. doi: 10.1016/j.msksp.2024.102952. Epub 2024 Apr 12.'}, {'pmid': '39062255', 'type': 'BACKGROUND', 'citation': 'Chen C, Xu J, Li H. Effects of Schroth 3D Exercise on Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Children (Basel). 2024 Jul 1;11(7):806. doi: 10.3390/children11070806.'}, {'pmid': '28033399', 'type': 'BACKGROUND', 'citation': 'Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.'}, {'pmid': '27525315', 'type': 'BACKGROUND', 'citation': "Berdishevsky H, Lebel VA, Bettany-Saltikov J, Rigo M, Lebel A, Hennes A, Romano M, Bialek M, M'hango A, Betts T, de Mauroy JC, Durmala J. Physiotherapy scoliosis-specific exercises - a comprehensive review of seven major schools. Scoliosis Spinal Disord. 2016 Aug 4;11:20. doi: 10.1186/s13013-016-0076-9. eCollection 2016."}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the effects of augmented reality (AR)-based exercise training in adolescents with idiopathic scoliosis. Participants are randomly assigned to either a control group receiving conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) or an intervention group receiving AR-assisted PSSE-Schroth exercises. The primary outcomes include body awareness, trunk appearance perception, and exercise adherence. The study aims to evaluate whether AR-assisted training provides additional benefits over conventional therapy in improving postural control, perception, and compliance in scoliosis management.', 'detailedDescription': 'Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may negatively affect posture, body image, and adherence to exercise-based rehabilitation. While Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) are widely accepted as a conservative treatment method, adherence and perception-related factors remain challenging.\n\nThis study is designed as a parallel-group, randomized controlled trial comparing conventional PSSE-Schroth exercises with AR-assisted PSSE-Schroth training. A total of 30 adolescents diagnosed with AIS were enrolled and randomized into two groups:\n\nControl Group: received supervised PSSE-Schroth exercises.\n\nIntervention Group: received supervised AR-assisted PSSE-Schroth exercises.\n\nThe intervention lasted 12 weeks, and participants were evaluated at baseline and post-intervention.\n\nPrimary outcome measures include body awareness (Awareness-Body-Chart), trunk appearance perception (Walter Reed Visual Assessment Scale, Spinal Appearance Questionnaire), and exercise adherence (Exercise Adherence Rating Scale).\n\nSecondary outcome measures include Cobb angle, vertebral rotation, pain intensity, and treatment satisfaction.\n\nThe study hypothesizes that AR-assisted PSSE-Schroth training will enhance body awareness, improve trunk appearance perception, and increase adherence compared to conventional methods. This research may provide new insights into integrating digital technologies into scoliosis rehabilitation and contribute to developing innovative, patient-centered approaches in physiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdolescents clinically diagnosed with idiopathic scoliosis (AIS)\n\nCobb angle between 10° and 30°\n\nAge range: 10-18 years\n\nNo history of spinal surgery\n\nAbility to regularly participate in the exercise program\n\nSigned informed consent obtained from both participants and their parents\n\nExclusion Criteria:\n\nDiagnosis of neuromuscular, congenital, or secondary scoliosis\n\nPrevious history of spinal surgery\n\nPresence of severe cardiovascular, respiratory, or musculoskeletal conditions preventing participation in exercise\n\nVisual, auditory, or perceptual impairments that would hinder participation in augmented reality-based training\n\nConcurrent participation in another physiotherapy or rehabilitation program during the study period'}, 'identificationModule': {'nctId': 'NCT07201103', 'acronym': 'AR-SCOLIO', 'briefTitle': 'Augmented Reality-Based Exercise Training in Adolescents With Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'The Effects of Augmented Reality-Based Exercise Training on Body Awareness, Trunk Appearance Perception, and Exercise Adherence in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '323S271'}, 'secondaryIdInfos': [{'id': 'TÜBİTAK 1001 Projesi - 323S271', 'type': 'OTHER_GRANT', 'domain': 'TUBITAK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Conventional PSSE-Schroth', 'description': 'Participants in this group received supervised conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The program included one 45-minute supervised session per week, complemented by home exercises. Established scoliosis rehabilitation protocols focusing on posture correction, breathing, and spinal alignment were followed.', 'interventionNames': ['Behavioral: Conventional PSSE-Schroth']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental - AR-assisted PSSE-Schroth', 'description': 'Participants in this group received supervised augmented reality (AR)-assisted Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The intervention included one 45-minute supervised session per week, supplemented with home exercises. Augmented reality technology was used to provide real-time visual and kinesthetic feedback, aiming to enhance posture correction, breathing patterns, and spinal alignment.', 'interventionNames': ['Behavioral: AR-Assisted PSSE-Schroth']}], 'interventions': [{'name': 'Conventional PSSE-Schroth', 'type': 'BEHAVIORAL', 'otherNames': ['Schroth Method'], 'description': 'Participants performed conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The program consisted of one 45-minute supervised session per week complemented by home-based exercises. The exercises focused on posture correction, spinal alignment, and corrective breathing techniques according to standard scoliosis rehabilitation protocols.', 'armGroupLabels': ['Control - Conventional PSSE-Schroth']}, {'name': 'AR-Assisted PSSE-Schroth', 'type': 'BEHAVIORAL', 'otherNames': ['Augmented Reality Exercise Training'], 'description': 'Participants performed Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) enhanced with augmented reality (AR) support for 4 weeks. The intervention included one 45-minute supervised session per week, plus home-based exercises. The AR system provided real-time visual and kinesthetic feedback during exercise sessions to improve body awareness, trunk appearance perception, and adherence.', 'armGroupLabels': ['Experimental - AR-assisted PSSE-Schroth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27010', 'city': 'Gaziantep', 'state': 'Şahinbey', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'name': 'Adnan B Coşkun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasan Kalyoncu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "At this stage, the decision on sharing individual participant data (IPD) is undecided. As the study is supported by TÜBİTAK (The Scientific and Technological Research Council of Turkey), any data sharing must comply with the funder's policies, ethical approval requirements, and national data protection regulations. The research team is committed to transparency and is open to sharing de-identified, anonymized data upon reasonable request from qualified researchers. Such sharing will only take place after publication of the study results, and contingent upon TÜBİTAK's approval and the execution of appropriate data-sharing agreements to ensure participant confidentiality and compliance with legal and ethical standards."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst.Prof.Dr.', 'investigatorFullName': 'Adnan Batuhan Coskun', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}