Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05026294
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plyometric Exercise With Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059385', 'term': 'Plyometric Exercise'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise 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': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Pretest-posttest control group design was used. A sample of 47 male children participated in the current study. After gathering the baseline measurements, the participants were randomly assigned into three groups: experimental group I, (EGI) contained 16 participants, experimental group II (EGII) contained 16 participants, and control group, (CG) contained 15. The stratification was done using sealed envelopes. The children were not aware of their group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot posture', 'timeFrame': '10 weeks', 'description': 'condition of the medial longitudinal arch of the foot'}, {'measure': 'Balance (measure 1)', 'timeFrame': '10 weeks', 'description': 'Perimeter area (mm).'}, {'measure': 'Balance (measure 2)', 'timeFrame': '10 weeks', 'description': 'Ellipse area (mm2).'}, {'measure': 'Balance (measure 3)', 'timeFrame': '10 weeks', 'description': 'Standard backward-forward deviation.'}, {'measure': 'Balance (measure 4)', 'timeFrame': '10 weeks', 'description': 'Standard medial-lateral deviation.'}, {'measure': 'Functional mobility', 'timeFrame': '10 weeks', 'description': 'Timed up and go test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flat Feet']}, 'descriptionModule': {'briefSummary': 'Obesity is one of the main factors that contribute to an acquired flat foot deformity which in turn impairs the balance strategies. The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture, and functional mobility in obese children with flexible flatfoot.', 'detailedDescription': 'A sample of 47 male children participated in the current study. The participants were selected from different elementary schools in Taif, Saudi Arabia. Their age ranged from 7 to 11 years. the sample was randomly divided into 3 groups: the experimental group I, (EGI), the experimental group II, (EGII), and the control group (CG). The EGI received a plyometric exercise program. The EGII received the corrective exercises 2 sessions per week for 10 weeks. The control group did not perform any planned physical activities during the intervention period but continued in their routine physical activities. The Prokin system was used to assess the static balance, timed up and go test was used to assess functional mobility, and Navicular drop test was used to assess the degree of flatfoot deformity, prior to and after the intervention for all groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'genderBased': True, 'genderDescription': 'A sample of 47 male children participated in the current study without having female participants because of the cultural perspective.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index percentile equal to or greater than the 95th percentile\n* All had no previous history of strength or balance training or involvement in competitive sports emphasizing muscular strength or balance.\n* All participants had balance deficiency and mobile flat foot.\n\nExclusion Criteria:\n\n* Previous injury to the lower limb required medical care.\n* Confounding conditions, such as a deformity of or surgery in the lower limb.\n* visual impairment, or neuromuscular disorders.\n* engagement in obesity treatment programs, three months prior to the study.'}, 'identificationModule': {'nctId': 'NCT05026294', 'briefTitle': 'Plyometric Exercise With Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Taif University'}, 'officialTitle': 'Effects of Plyometric Exercises Versus Flatfoot Corrective Exercises on Postural Control and Foot Posture in Obese Children With Flexible Flatfoot', 'orgStudyIdInfo': {'id': 'HAP-02-T-067- 452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group I', 'description': 'The experimental group received plyometric training', 'interventionNames': ['Other: plyometric exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group II', 'description': 'The experimental group received flat feet rehabilitation training', 'interventionNames': ['Other: Exercises for flat feet rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "The Control group didn't receive intervention"}], 'interventions': [{'name': 'plyometric exercises', 'type': 'OTHER', 'description': 'Exercises for strength and flexibility', 'armGroupLabels': ['Experimental group I']}, {'name': 'Exercises for flat feet rehabilitation', 'type': 'OTHER', 'description': 'Exercises for intrinsic muscles strength', 'armGroupLabels': ['Experimental group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62552', 'city': "Ta'if", 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'College of Applied Medical Sciences', 'geoPoint': {'lat': 21.27028, 'lon': 40.41583}}], 'overallOfficials': [{'name': 'Hatem Allam, A.professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taif University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hatem Allam', 'investigatorAffiliation': 'Taif University'}}}}