Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-03 @ 2:24 AM
Study NCT ID:
NCT03731767
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pretest post test study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tendon length', 'timeFrame': 'Measure 1 prior to manipulation. Measure 2 immediately after manipulation, within 5 minutes (the same day)', 'description': 'Change in ankle ligament length in millimeters measured by a method of musculoskeletal Ultrasound imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Manipulation', 'Thrust', 'Ankle', 'Ligaments'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Measure the effect of a common used ankle manipulation on ligament length in the ankle.', 'detailedDescription': 'The purpose of this study is to determine what the effect of a common ankle manipulation on the supporting ligaments of the ankle.\n\nDesign: The researchers will conduct a quasi-experimental study with a method of convenience sampling. The design of this study will allow to determine what the direct effect of a common a commonly used physical therapy ankle manipulation is on the length of the soft tissue connection between the smaller bone in the lower leg and the heel bone and the smaller bone in the leg and the ankle bone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18-65 years old\n2. No current trauma to the ankle/ foot-if not present both ankles will be used during this study\n3. No hx of fracture or surgical intervention to the ankle\n\nExclusion Criteria:\n\n1. Red flags identified during the subjects intake. If manipulation is contraindicated the subjects will be removed from the study.\n2. History of ankle/ foot trauma within the last 3 months.\n3. History of surgery on the ankle/ foot.\n4. History of knee, hip, or lower back related issues that would make the application of the ankle manipulation contraindicated.\n5. Workers compensation and any pending legal action regarding ankle/ foot related issues.\n6. Undergone any ankle manipulation within the last 3 weeks.\n7. History of Osteopenia or Osteoporosis.\n8. Inability to undergo measuring protocol.'}, 'identificationModule': {'nctId': 'NCT03731767', 'briefTitle': 'The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Florida Gulf Coast University'}, 'officialTitle': 'The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals', 'orgStudyIdInfo': {'id': 'FloridaGCU 2018-50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subject group', 'description': 'Distraction thrust manipulation of the talocural joint in supine position', 'interventionNames': ['Procedure: Distraction thrust manipulation']}], 'interventions': [{'name': 'Distraction thrust manipulation', 'type': 'PROCEDURE', 'description': 'Distraction thrust manipulation of the talocural joint in supine position', 'armGroupLabels': ['Subject group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33914', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Therapy Practice PC', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}], 'overallOfficials': [{'name': 'Rob Sillevis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FGCU Assistent Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Gulf Coast University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}