Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00971451
Status:
UNKNOWN
Last Update Posted:
2011-03-08
First Post:
2009-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-04', 'studyFirstSubmitDate': '2009-09-02', 'studyFirstSubmitQcDate': '2009-09-02', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quadriceps muscle strength and inhibition using the quadriceps central activation ratio', 'timeFrame': 'Day 15'}], 'secondaryOutcomes': [{'measure': 'Quadriceps H-reflex testing', 'timeFrame': 'Day 15'}, {'measure': 'International Knee Documentation Committee Subjective Knee Joint Evaluation', 'timeFrame': 'Day 15'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Day 15'}, {'measure': 'Tegner Activity Rating', 'timeFrame': 'Day 15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament', 'ACL'], 'conditions': ['Rupture of Anterior Cruciate Ligament']}, 'descriptionModule': {'briefSummary': 'Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.\n\nAll subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Complete ACL rupture\n2. Age 15-55\n\nExclusion Criteria:\n\n1. Persons who cannot tolerate knee joint TENS.\n2. Persons who have a known allergy to cryotherapy\n3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.'}, 'identificationModule': {'nctId': 'NCT00971451', 'briefTitle': 'Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '13398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'knee joint cryotherapy', 'description': '20 minutes of knee joint cryotherapy - ice bag application', 'interventionNames': ['Other: cryotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'TENS', 'description': 'continuous TENS for duration of the 1 hour exercise session', 'interventionNames': ['Other: TENS']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'no modality intervention; just exercise'}], 'interventions': [{'name': 'cryotherapy', 'type': 'OTHER', 'description': '20 minutes of knee joint cryotherapy - ice bag application', 'armGroupLabels': ['knee joint cryotherapy']}, {'name': 'TENS', 'type': 'OTHER', 'description': 'continuous use of TENS during the exercise session', 'armGroupLabels': ['TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph M Hart, PhD', 'role': 'CONTACT', 'email': 'jmh3zf@virginia.edu', 'phone': '434-243-0256'}, {'name': 'Joseph M Hart, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Joseph M Hart, Ph.D.', 'role': 'CONTACT', 'email': 'jmh3zf@hscmail.mcc.virginia.edu', 'phone': '434-243-0256'}], 'overallOfficials': [{'name': 'Joseph M Hart, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joseph M. Hart, Ph.D., Assistant Professor', 'oldOrganization': 'University of Virginia'}}}}