Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT01250860
Status:
COMPLETED
Last Update Posted:
2010-12-01
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-11-30', 'lastUpdatePostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simultaneous use of two physiotherapeutic methods in the treatment of Adolescent Idiopathic Scoliosis', 'timeFrame': '3 weeks', 'description': 'Forty-two girls with thoracic AIS; mean age - 14.5y. Cobb - (range 12-40) The group was divided into two randomized subgroups. DoboMed was applied in group "D" only. DoboMed and manual therapy (Kaltenborn) were applied in group "DK". The spirometry, the strength of respiratory muscles (maximal inspiratory and expiratory pressures- MIP, MEP), kyphosis (plurimeter-V) and the angle of trunk rotation (ATR) in thoracic part (Bunnell scoliometer) were estimated twice - before and after therapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Manual therapy', 'DoboMed exercise', 'Spirometric test'], 'conditions': ['The Spirometry;', 'The Strength of Respiratory Muscles - MIP, MEP;', 'Kyphosis (Plurimeter-V)', 'The Angle of Trunk Rotation in Thoracic Part']}, 'descriptionModule': {'briefSummary': 'The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* girls aged 10 to 16\n* one arc right side curve\n* Cobb range 12 - 40 degrees\n\nExclusion Criteria:\n\n* bigger Cobb range\n* double arc curve\n* no parent approval\n* lack of cooperation'}, 'identificationModule': {'nctId': 'NCT01250860', 'briefTitle': 'Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study', 'orgStudyIdInfo': {'id': 'BW-08-AM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Control DoboMed group - only specific active exercises: symmetrical positions for exercising; asymmetrical active movements; thoracic spine kyphotization; transverse plane derotation; apical area involvement; concave ribs mobilization; exteroceptive facilitation; respiration-directed movements of the thorax and spine; three-dimensional displacement of vertebra; active autocorrection.', 'interventionNames': ['Behavioral: Sham therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Experimental DoboMed and Kaltenborn manual therapy. Suitable techniques were chosen according to manual examination: cervical spine; thoracic spine; lumbar spine; costovertebral articles; pelvis position. During the 15 sessions in group "DK" we used:derotational manual terapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method; the manual techniques used in continuation study were different from techniques in pilot study.', 'interventionNames': ['Other: Derotational manual therapy techniques in selected segments in spine']}], 'interventions': [{'name': 'Derotational manual therapy techniques in selected segments in spine', 'type': 'OTHER', 'description': 'Derotational manual therapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method.', 'armGroupLabels': ['Experimental group']}, {'name': 'Sham therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40-055', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Medical University of Silesia', 'oldOrganization': 'Department of rehabilitation'}}}}