Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05177302
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAGOS-C', 'timeFrame': 'immediately after the intervention', 'description': 'The individuals will be asked to complete 37 items of the HAGOS-C after instruction'}, {'measure': 'SF-36v2', 'timeFrame': 'immediately after the intervention', 'description': 'The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation'}, {'measure': 'HAGOS-C', 'timeFrame': 'after 1 week', 'description': 'The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability.'}, {'measure': 'HAGOS-C', 'timeFrame': 'after 4 months', 'description': 'The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip and/ or groin pain', 'reliability', 'validity', 'responsiveness', 'HAGOS'], 'conditions': ['Patient Reported Outcome']}, 'descriptionModule': {'briefSummary': 'Hip and groin pain is a common injury in athletes participating multidirectional sports, and resulting in decreased sports participation and quality of life. The Copenhagen Hip And Groin Outcome Score (HAGOS) specifically targets young to middle-aged physically active individuals with long-standing hip and/ or groin pain, it consists of six separate subscales about symptoms, pain, physical function in daily living, physical function in sports and recreation, participation in physical activities and hip and/ or groin related quality of life (QoL), which all subscales have shown to have adequate validity, reliability and responsiveness in the original version of the questionnaire. Lacking of the specifical questionnaire for physically active people with hip and/or groin pain, the purpose of the study is to translate and cross-culturally adapt HAGOS into Chinese version (HAGOS-C) according to the guidelines from Beaton et al.', 'detailedDescription': 'Hip and groin pain is a common injury in athletes participating multidirectional sports, and resulting in decreased sports participation and quality of life. The Copenhagen Hip And Groin Outcome Score (HAGOS) specifically targets young to middle-aged physically active individuals with long-standing hip and/ or groin pain, it consists of six separate subscales about symptoms, pain, physical function in daily living, physical function in sports and recreation, participation in physical activities and hip and/ or groin related quality of life (QoL), which all subscales have shown to have adequate validity, reliability and responsiveness in the original version of the questionnaire. Lacking of the specifical questionnaire for physically active people with hip and/or groin pain, the purpose of the study is to translate and cross-culturally adapt HAGOS into Chinese version (HAGOS-C) according to the guidelines from Beaton et al.\n\nWe translated the questionnaire from the English version involved following steps: (1)initial translation with two bilingual translators (2) holding consensus meeting for the preliminary Chinese version (3) back translation with other two bilingual back translators (4) another consensus meeting for ensuring the consistency with original English version (5) pretesting for wording and understanding (6) Wording, rephrasing and format corrected to obtain final Chinese version of the HAGOS.\n\nThe aim of the study is to determine the validity, reliability and responsiveness of HAGOS-C by recruiting young to middle-aged physically active individuals with long-standing hip and/ or groin pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The individuals with long-standing hip and/ or groin pain lasting 2 to 6 month, which hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint, and tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis will be included . The individuals with other symptoms in lumbar, knee or ankle joint will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically active at least 2.5 hrs/week\n* tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis\n* hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint.\n* pain lasting for 2 to 6 month and no obvious changes within 3 week recently.\n\nExclusion Criteria:\n\n* other symptoms in lumbar, knee or ankle joint.'}, 'identificationModule': {'nctId': 'NCT05177302', 'briefTitle': 'Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 3', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(3)', 'orgStudyIdInfo': {'id': 'YM110027E(3)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with hip and/ or groin pain', 'description': 'The young to middle-aged physically active individuals with hip and/ or groin pain, which symptoms lasting for 2 to 6 month.', 'interventionNames': ['Other: HAGOS-C', 'Other: SF-36v2']}], 'interventions': [{'name': 'HAGOS-C', 'type': 'OTHER', 'description': 'The subjects will be instructed to complete HAGOS-C at the initial contact and again after 1 week and 4 month for reliability and responsiveness test, respectively', 'armGroupLabels': ['Individuals with hip and/ or groin pain']}, {'name': 'SF-36v2', 'type': 'OTHER', 'description': 'The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C', 'armGroupLabels': ['Individuals with hip and/ or groin pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11221', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Yang Ming University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yi-Fen Shih, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yi-Fen Shih', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}