Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT04315220
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2020-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corestability Training in Overweight Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D000073296', 'term': 'Noncommunicable Diseases'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two group pre-test post-test design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot pressure distribution', 'timeFrame': 'change from baseline and six weeks', 'description': 'All overweight children will be asked to walk barefoot along a 5-.metre walkway using Harris mat pressure distribution platform which will be placed on a firm, level surface, in the centre of walkway. Children will be ensured to step on the Harris mat without pause, first with one foot and then repeat the same procedure with the other foot at constant speed. Foot markings then analyzed by using'}, {'measure': 'Single limb stance', 'timeFrame': 'change from baseline and six weeks', 'description': 'The children will be instructed to stand on the dominant leg with non dominant leg flexed to 90 degree, and maintain the position. The test will be performed first with eyes open and then with the eyes closed. The time for which participant will be able to maintain balance will be recorded'}, {'measure': 'Y- reach set', 'timeFrame': 'change from baseline and six weeks', 'description': 'The participant will stand on one foot in the center of the Y with the most distal aspect of the toes just behind the starting line. While maintaining single-leg stance, the balance will be tested in the anterior, postero-medial and postero-lateral direction with reach foot. The reach distance in all the three directions will be noted.'}, {'measure': 'Core Strength', 'timeFrame': 'change from baseline and six weeks', 'description': 'The core strength will be measured with the Chattanooga Pressure Biofeedback Unit. The device will be placed under the lumbar spine in crook lying and inflated to a baseline of 40 mmHg. The participants will be instructed to perform drawing-in maneuver on the verbal instructions, maintain it for 10 sec. The change in pressure will be noted'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Noncommunicable disease', 'Balance', 'Posture', 'Childhood obesity', 'Overweight'], 'conditions': ['Childhood Obesity', 'Child Obesity', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'A total of 52 overweight children aged between eight and sixteen years will be recruited by criterion based purposive sampling to participate in the two groups pretest post test randomized clinical study. Random allocation of the eligible subjects for treatment will be done by the block randomization method with matrix of thirteen rows and four columns (13x4). The subject will be allotted to the group randomly, based on the chit selected by the person other the primary researcher.Once the block is filled, the next row block will be opened. Thus equal distribution of overweight children in the each group will be ensured.\n\nGroup A will be receiving actual core stability training (Level 1 - Mat exercises and Level 2 - Swiss Ball exercises) for 6 weeks with a frequency of three sessions per week.Group B will receive no training. Each session will last for 30 minutes of duration. The static and dynamic balance, foot pressure distribution and core strength will be assessed at the baseline and at the end of the treatment sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children of age 8- 16 years old.\n2. Both Boys and Girls.\n3. Child with BMI-for-age percentile growth between 85th to less than 95th percentile.\n\nExclusion Criteria:\n\n1. Uncooperative participants.\n2. Upper or lower limb fracture or injury in recent 6 months.\n3. Any musculoskeletal or neurological disorder affecting core strength and balance.\n4. Refuse to participate because not able to understand the researcher instructions.\n5. Unable to attend the whole sessions during the research period.'}, 'identificationModule': {'nctId': 'NCT04315220', 'briefTitle': 'Corestability Training in Overweight Children', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'Effectiveness of Core Stability Training in Improving Postural Stability and Foot Pressure Distribution in Overweight Children: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MMDU/2020'}, 'secondaryIdInfos': [{'id': 'U1111-1249-8305', 'type': 'OTHER', 'domain': 'Universal Trial Number (UTN) by WHO ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group (Core stability training (CST))', 'description': 'Core stability training (CST) consists of two levels: level 1- Mat exercises (includes abdominal muscle contraction, bridging,cat stretch,single leg circle and superman) and level 2- Swiss ball exercises (includes abdominal muscle contraction, bridging and squatting by using therapy ball).\n\nThere will be three sets of 15 repetitions of each exercises. The first set will consist of 10 seconds hold period, follow by 12 seconds hold in second set and 15 seconds hold in third set respectively. The entire session will last for approximately 30 minutes.', 'interventionNames': ['Other: Corestability training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Will not receive any kind of training.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'Corestability training', 'type': 'OTHER', 'description': 'Level -1: Mat exercises\n\nAbdominal muscle contraction,bridging,cat stretch,single limb circle and superman.:\n\nLevel- 2: Swiss Ball Exercises Abdominal contraction,bridging and squats.', 'armGroupLabels': ['Experimental group (Core stability training (CST))']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133207', 'city': 'Ambāla', 'state': 'Haryana', 'country': 'India', 'facility': 'Kanu Goyal', 'geoPoint': {'lat': 30.36099, 'lon': 76.79782}}], 'overallOfficials': [{'name': 'Kanu Goyal, BPT, DOMTP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation'}, {'name': 'Asir J Samuel, MPT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Once (Before the start start)', 'ipdSharing': 'YES', 'description': 'Detail protocol will be published highlighting methods, statistical plan and Informed consent form', 'accessCriteria': 'Mendeley data Upload'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asir John Samuel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maharishi Markandeshwar International School', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Asir John Samuel', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}