Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02799394
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055034', 'term': 'Osteochondrosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-27', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported recovery on a 7-point Likert scale', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Self-reported recovery on a 7-point Likert scale', 'timeFrame': '4 and 8 weeks + 6 and 12 months after inclusion.'}, {'measure': 'Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"', 'timeFrame': '4, 8 and 12 weeks + 6 and 12 months after inclusion.'}, {'measure': 'Isometric hip and knee extension strength assessed using a strap-mounted dynamometer', 'timeFrame': '4, 8 and 12 weeks after inclusion.'}, {'measure': 'Pressure pain thresholds at tuberositas patella, center of patella and lateral elbow assessed by a hand held pressure algometer.', 'timeFrame': '4, 8 and 12 weeks after inclusion.'}, {'measure': 'Thigh circumference measured using tape measure.', 'timeFrame': '4, 8 and 12 weeks after inclusion.'}, {'measure': 'Vertical jump for height [calculated as the difference between reach height and maximal jump height. This will be measured using a ruler]', 'timeFrame': '4, 8 and 12 weeks after inclusion.'}, {'measure': 'Single leg jump for distance (defined as the maximal length the subject can jump on one leg. Measured using a ruler).', 'timeFrame': '4, 8 and 12 weeks after inclusion.'}, {'measure': 'Flexibility of the hamstrings and quadriceps [measured using goniometer].', 'timeFrame': '4, 8 and 12 weeks after inclusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osgood Schlatter Disease']}, 'referencesModule': {'references': [{'pmid': '32284945', 'type': 'DERIVED', 'citation': 'Rathleff MS, Winiarski L, Krommes K, Graven-Nielsen T, Holmich P, Olesen JL, Holden S, Thorborg K. Activity Modification and Knee Strengthening for Osgood-Schlatter Disease: A Prospective Cohort Study. Orthop J Sports Med. 2020 Apr 6;8(4):2325967120911106. doi: 10.1177/2325967120911106. eCollection 2020 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of activity modification, exercises and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The adolescents will be recruited from primary schools, general practitioners and through online advertising on Facebook.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10-14 years of age\n* Pain at tuberositas patellae during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation\n* Pain during palpation of tuberositas patellae\n* Knee pain for 6 weeks or more\n\nExclusion Criteria:\n\n* Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).\n* Previous surgery\n* Pain from the hip or back that interferes with activities of daily living.\n* Habitual patella luxations\n* Clinical suspicion of meniscal lesion'}, 'identificationModule': {'nctId': 'NCT02799394', 'briefTitle': 'Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.', 'orgStudyIdInfo': {'id': 'N- 20140100-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activity modification, exercises and gradual return to sport', 'interventionNames': ['Other: Activity modification, exercises and gradual return to sport']}], 'interventions': [{'name': 'Activity modification, exercises and gradual return to sport', 'type': 'OTHER', 'armGroupLabels': ['Activity modification, exercises and gradual return to sport']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'The North Denmark Region', 'country': 'Denmark', 'facility': 'Aalborg Universitetshospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre-Amager Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be made publicly available no later than six months after the final publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Michael Skovdal Rathleff', 'investigatorAffiliation': 'Aalborg University'}}}}