Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 8:15 AM
Study NCT ID:
NCT04922268
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Focus of Attention Posttraumatic Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in lower extremity biomechanics during walking', 'timeFrame': '1-week post-intervention, 4-weeks post-intervention', 'description': 'Knee and hip angles and loads measured via 3D biomechanics'}, {'measure': 'Knee cartilage health', 'timeFrame': '1-week post-intervention, 4-weeks post-intervention', 'description': 'Knee cartilage thickness measured using diagnostic ultrasound imaging'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries', 'Anterior Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Tear', 'Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment\n* cleared to return to full activity by treating orthopedic surgeon\n\nExclusion Criteria:\n\n* Body mass index \\>35 kg/m2\n* History of musculoskeletal injury sustained 3 months prior to enrollment\n* Current participation in formal post-operative rehabilitation'}, 'identificationModule': {'nctId': 'NCT04922268', 'briefTitle': 'External Focus of Attention Posttraumatic Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Charlotte'}, 'officialTitle': 'External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction', 'orgStudyIdInfo': {'id': '22-0089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Internal focus of attention feedback', 'description': 'Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.', 'interventionNames': ['Other: Internal focus of attention feedback']}, {'type': 'EXPERIMENTAL', 'label': 'External focus of attention feedback', 'description': 'Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.', 'interventionNames': ['Other: External focus of attention feedback']}], 'interventions': [{'name': 'Internal focus of attention feedback', 'type': 'OTHER', 'description': 'Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.', 'armGroupLabels': ['Internal focus of attention feedback']}, {'name': 'External focus of attention feedback', 'type': 'OTHER', 'description': 'Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.', 'armGroupLabels': ['External focus of attention feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28223', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Charlotte', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arthritis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Abbey Thomas, PhD', 'investigatorAffiliation': 'University of North Carolina, Charlotte'}}}}