Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05831904
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-04-16', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle activation values on surface electromyography(sEMG)', 'timeFrame': '10 seconds for each session', 'description': 'surface muscle contraction of bilateral hip girdle muscles\n\nbilateral gluteus medius, tensor fascia lata, iliopsoas, rectus femoris muscles'}], 'secondaryOutcomes': [{'measure': 'VAS (Visual Analogue Scale)', 'timeFrame': '10 seconds for each session', 'description': 'a psychometric scale that is generally used in pain scale surveys and this study participants will be asked to scale the uncomfortable feelings during the vibration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Dislocation']}, 'descriptionModule': {'briefSummary': 'This clinical trial(prospective, pilot study) is to learn about the effect of whole-body vibration on hip girdle muscles in healthy children as a primary study aiming for a new clinical intervention protocol to prevent hip dislocation in patients with severe cerebral palsy.', 'detailedDescription': 'Design: Prospective, pilot study Setting: hospital rehabilitation department Intervention: Participants will be asked to walk and jump with a surface electromyography(EMG) attached to their hip girdle muscles. After the participants are positioned(standing) on the platform of whole-body vibration device, the study practitioner will record the sEMG values from the hip girdle muscles during the vibration applied. The mean values of repeating the same process with different vibrations applications and the values before vibration will be compared by using the SPSS using the paired "t-test" or Wilcoxon signed rank test for comparison between before and after vibration in the same group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children (5 to 15 years old)\n\nExclusion Criteria:\n\n* Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities\n* Children who underwent hip joint surgery'}, 'identificationModule': {'nctId': 'NCT05831904', 'briefTitle': 'Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People', 'orgStudyIdInfo': {'id': 'B-2212-801-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 healthy children', 'description': '20 healthy children aged 5 to 15 years , without any congenital or developmental abnormalities of their hip joint', 'interventionNames': ['Device: whole-body vibration']}], 'interventions': [{'name': 'whole-body vibration', 'type': 'DEVICE', 'description': 'After attaching the surface electromyography(EMG) to bilateral hip girdle muscles, participants will walk and jump at their comfortable speed. After investigator record the muscle activation values, participants will be asked to stand on the vibration device. While the whole-body vibration is applied, the hip girdle muscles activation values will be recorded accordingly via sEMG.', 'armGroupLabels': ['20 healthy children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Juseok Ryu, M.D, PhD', 'role': 'CONTACT', 'email': 'jseok337@snu.ac.kr', 'phone': '+82-31-787-7739'}], 'facility': 'Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Ju Seok Ryu, M.D. PhD', 'role': 'CONTACT', 'email': 'jseok337@snu.ac.kr', 'phone': '+82-31-787-7739'}], 'overallOfficials': [{'name': 'Ju Seok Ryu, M.D. PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ju Seok Ryu', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}