Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-01 @ 9:16 PM
Study NCT ID:
NCT05479695
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis
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': ['PARTICIPANT'], 'maskingDescription': '54 pre-filled sealed envelopes were prepared for the randomization process of the participants who met the inclusion and exclusion criteria determined in the study. 27 envelope series consists of 1 number and 27 envelope series consists of 2 number. The control group (KG) using Chêneau type spinal orthosis was given number 1, and the group using Chêneau type spinal orthosis and insoles (TG) was given number 2. Each of the participants chose one of the sealed envelopes in turn. Participants included in the study were randomly assigned to the KG group or the TG group according to the number on the selected envelope.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The first group uses spinal orthoses. The second group uses spinal orthosis and insoles.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk test', 'timeFrame': 'Change from Baseline of treatment at 3 months', 'description': 'assessment of functional capacity'}, {'measure': 'Scoliosis Research Society (SRS-22 test)', 'timeFrame': 'Change from Baseline of treatment at 3 months', 'description': 'assessment of quality of life'}, {'measure': 'sway balance test', 'timeFrame': 'Change from Baseline of treatment at 3 months', 'description': 'assessment of postural balance'}, {'measure': 'plantar pressure analysis', 'timeFrame': 'Change from Baseline of treatment at 3 months', 'description': 'static and dynamic plantar pressure analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent Idiopathic Scoliosis', 'Scoliosis Brace', 'Insoles'], 'conditions': ['Scoliosis; Adolescence', 'Pressure Area', 'Scoliosis', 'Orthosis']}, 'descriptionModule': {'briefSummary': 'Adolescent Idiopathic Scoliosis; by problem of stabilty causes postural changes, because of this reason patient with scoliosis needs to assesment by risk of balance. Postural adjustments are required, both in a static stance and during walking. Insoles from foot orthoses support better postural balance and control.\n\nIt has been reported that approximately 87% of scoliosis patients have pelvic asymmetry, and patients with scoliosis with a Cobb angle of 15⁰ or more have balance problems in their feet. Foot orthoses (FO) correct pelvic asymmetry and reduce lower extremity joint angles during walking.\n\nIn the literature, although there are studies such as balance assessment and plantar pressure analysis in Adolescent Idiopathic Scoliosis (AIS) patients, there are not enough studies on the effect of insoles used in scoliosis patients, and it has been observed that there is no study on the effect of insoles on treatment in patients using spinal orthosis.\n\nThe aim of this study is to investigate the effect of insoles on the treatment of scoliosis patients using Chêneau type spinal orthosis.\n\nIn the study; The effect of insoles on patients with 20-45⁰ curvature, adolescent idiopathic scoliosis and using Chêneau type spinal orthosis; It was planned to investigate the groups using and not using insoles at the beginning of the treatment and after 3 months of follow-up by comparing the results of Cobb angle measurement, functional capacity assessment test, quality of life assessment test, balance test and plantar pressure analysis.', 'detailedDescription': 'Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine that is commonly seen in individuals aged 10-19 years, and spinal orthosis application, one of the conservative treatment methods, is widely preferred today. Spinal orthosis application in individuals with scoliosis may adversely affect functional capacity, quality of life, balance and plantar pressure. The aim of this study is to determine the use of insoles for 3 months in AIS individuals using Chêneau type spinal orthosis functional capacity, quality of life, balance and the effect of plantar pressure is to investigate. Study group included 42 individuals aged between 10-19 with a Cobb angle of 20-45⁰. Participants were randomly separated into 2 groups; Control-KG (n=21) and using insoles-TG (n=21). While only Chêneau type spinal orthosis was applied to KG group for 3 months, Chêneau type spinal orthosis and insoles were applied to TG group. Measurements were repeated after one week of spinal orthosis application and at the end of the 3rd month. The 6 Minute Walk Test (6 MWT) was used to evaluate the functional capacity of the participants, the Scoliosis Research Society-22 (SRS-22) for quality of life, and the Sensor Medica Maxi pedobarographic device for balance and plantar pressure measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria;\n\n* Adolescent idiopathic scoliosis patients between the ages of 10-19\n* Cobb angle to be in the range of 20-45 °\n* Adolescent idiopathic scoliosis patients who will use Chêneau type spinal orthosis for the first time or who will be renewed with a Chêneau type spinal orthosis\n* Absence of neurological problems\n* Differences in plantar pressure analysis of the two lower extremities\n\nExclusion criteria;\n\n* Previously used insoles\n* Finding a neurological problem\n* Those with congenital lower extremity deformities\n* Patients with lower extremity length difference more than 2 cm'}, 'identificationModule': {'nctId': 'NCT05479695', 'briefTitle': 'The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effect of Insoles on Functional Capacity, Quality of Life, Balance and Plantar Pressure in Patient With Adolescent Idiopathic Scoliosis Using Chêneau Type Spinal Orthosis', 'orgStudyIdInfo': {'id': 'mervearslan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient who use spinal orthoses and insoles', 'description': 'Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities.', 'interventionNames': ['Device: Spinal Orthoses and Insoles']}, {'type': 'OTHER', 'label': 'Patient who use only spinal orthoses', 'description': 'Spinal Orthoses: Devices that used in spinal deformities.', 'interventionNames': ['Device: Spinal Orthoses']}], 'interventions': [{'name': 'Spinal Orthoses and Insoles', 'type': 'DEVICE', 'description': 'Evaluation of scoliosis treatment in people using spinal orthoses and insoles', 'armGroupLabels': ['Patient who use spinal orthoses and insoles']}, {'name': 'Spinal Orthoses', 'type': 'DEVICE', 'description': 'Evaluation of scoliosis treatment in people using spinal orthoses', 'armGroupLabels': ['Patient who use only spinal orthoses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34810', 'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sena OZDEMİR GORGU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'merve arslan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}