Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT05805995
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vertebral Derotation on Pulmonary Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).\n\nThe Control group received only posterior correction with routine chest physiotherapy (group B).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing', 'timeFrame': 'Five months', 'description': "Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung functions, vertebral derotation, chest intervention'], 'conditions': ['Adolescent Idiopathic Scoliosis', 'Scoliosis Idiopathic']}, 'referencesModule': {'references': [{'pmid': '15995121', 'type': 'BACKGROUND', 'citation': 'Kim YJ, Lenke LG, Bridwell KH, Kim KL, Steger-May K. Pulmonary function in adolescent idiopathic scoliosis relative to the surgical procedure. J Bone Joint Surg Am. 2005 Jul;87(7):1534-41. doi: 10.2106/JBJS.C.00978.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.', 'detailedDescription': "Sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). They were presented with idiopathic scoliosis for 6-12 month. Their mean Cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. Before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. All of them did not receive any physical therapy program prior to the operation.\n\nPatients were arranged randomly into two groups (1 and 2), each containing 30 patients. Group 1 (DRG) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (NDRG) received posterior correction and the same rehabilitation program given to group 1."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male patients suffering from adolescent idiopathic scoliosis.\n* Participant age ranged from 12- 18 years old.\n* All patients had the same medical care.\n* Participants have received a good explanation of the treatment and measurement device.\n* Treatment was conducted surgical intervention.\n\nExclusion Criteria:\n\n* Instability of patient's medical condition.\n* Presence of any diseases that could affect the study results.\n* Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions."}, 'identificationModule': {'nctId': 'NCT05805995', 'briefTitle': 'Effects of Vertebral Derotation on Pulmonary Functions', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis', 'orgStudyIdInfo': {'id': 'veretebral derotation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).', 'interventionNames': ['Procedure: vertebral derotation']}, {'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'The Control group received only posterior correction with routine chest physiotherapy (group B).', 'interventionNames': ['Procedure: vertebral derotation']}], 'interventions': [{'name': 'vertebral derotation', 'type': 'PROCEDURE', 'otherNames': ['INCENTIVE SPIROMETER'], 'description': '* Incentive spirometer (Mediciser): Used for breathing exercises.\n* Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.', 'armGroupLabels': ['control', 'intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed s ali, lecturer', 'role': 'CONTACT', 'email': 'dr.shawky_2011@cu.edu.eg', 'phone': '01068443366'}], 'facility': 'Faculty of Physical Therapy -Cu', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'NISREEN A EL AHASS, PROF', 'role': 'CONTACT', 'email': 'Zayedsameh40@yahoo.com', 'phone': '0237969108'}], 'facility': 'faculty of PT - cu', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'KHALED T AHMED, Asso Prof', 'role': 'CONTACT', 'email': 'khaled.takey@must.edu.eg', 'phone': '01115586016'}, {'name': 'abla H saleh, prof', 'role': 'CONTACT', 'email': 'Abla_hamed2000@yahoo.com', 'phone': '01001521055'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'January 2023 - June 2023', 'ipdSharing': 'YES', 'description': 'At first study protocol and informed consent', 'accessCriteria': 'consent'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asssociate Professor', 'investigatorFullName': 'Khaled Takey Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}