Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-01 @ 11:38 AM
Study NCT ID:
NCT04833868
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2021-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056147', 'term': 'Equine-Assisted Therapy'}], 'ancestors': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-04-03', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FVC in liters', 'timeFrame': 'ten weeks', 'description': 'change in FVC measured Using Spiromaster PC-10 Spirometer'}, {'measure': 'FEV1 in liters', 'timeFrame': 'ten weeks', 'description': 'change in FEV1 measured Using Spiromaster PC-10 Spirometer'}, {'measure': 'MVV in liters/min', 'timeFrame': 'ten weeks', 'description': 'change in MVV measured Using Spiromaster PC-10 Spirometer'}, {'measure': 'FEV1/FVC in percentage', 'timeFrame': 'ten weeks', 'description': 'change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer'}, {'measure': 'aerobic capacity', 'timeFrame': 'ten weeks', 'description': '6MWT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hippotherapy', 'Pulmonary Function', 'Idiopathic Scoliosis'], 'conditions': ['Scoliosis Idiopathic']}, 'descriptionModule': {'briefSummary': "BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that negatively impacts the respiratory system and physical conditioning in adolescents. Hippotherapy is an equestrian intervention that optimizes physical performance and mobility in a bunch of contexts; however, its influence on pulmonary function remains unclear.\n\nAIM: This research aimed to analyze the impact of ten weeks of hippotherapy combined with Schroth exercises on ventilatory function and aerobic capacity in AIS.\n\nDESIGN: Randomized Controlled Trial SETTING: Outpatients attend a single center that includes a rehabilitation room and recreational riding center.\n\nPOPULATION: Forty-five patients were arbitrarily recruited to the experimental (N= 22) and control group (N=23).\n\nMETHODS: Patients in the experimental group received 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks. The two groups attended a 60-minute session of Schroth's intervention, 3 times/ week for 10 weeks. Two-way ANOVA for between-group comparisons and independent t-test for within-group comparisons were used in the statistical analysis.", 'detailedDescription': 'A total of 45 patients (13 males and 32 females) participated in the current study. The participants were assigned to one of two groups in a random manner: an experimental group who received hippotherapy combined with Schroth Exercise and the control group who received only schorth exercise. (FVC, FEV1, FEV1/FVC, MVV, and 6MWT) were measured before and after 10 weeks intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all types of curves,\n* curves between 10 and 20 degrees (29),\n* Risser grade 0 to 5\n* the availability to be engaged in once a week visit\n\nExclusion Criteria:\n\nAdolescents with:\n\n* obstructive pulmonary diseases\n* associated neuromuscular diseases\n* recent infectious episodes in the previous two months\n* history of cardiovascular or psychological disorders\n* any significant history of riding horses'}, 'identificationModule': {'nctId': 'NCT04833868', 'briefTitle': 'Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Batterjee Medical College'}, 'officialTitle': 'Efficacy of Hippotherapy Combined With Schroth Exercises on Pulmonary Function and Aerobic Capacity in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hippotherapy combined with Schroth Exercise', 'description': "received hippotherapy combined with Schroth Exercise hippotherapy session for 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks in addition to 60-minute session Schroth's intervention, 3 times/ week for 10 weeks", 'interventionNames': ['Other: hippotherapy and schroth exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Schroth Exercise', 'description': "received Schroth's intervention for a 60-minute session, 3 times/ week for 10 weeks", 'interventionNames': ['Other: schroth exercise']}], 'interventions': [{'name': 'hippotherapy and schroth exercise', 'type': 'OTHER', 'description': 'pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise', 'armGroupLabels': ['hippotherapy combined with Schroth Exercise']}, {'name': 'schroth exercise', 'type': 'OTHER', 'description': 'pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise', 'armGroupLabels': ['Schroth Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Battarjee Medical College', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Mohamed M. Abdel Ghafar, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Batterjee Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Batterjee Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taif University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate Professor', 'investigatorFullName': 'Mohamed A. Abdel Ghafar', 'investigatorAffiliation': 'Batterjee Medical College'}}}}