Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-04 @ 1:35 AM
Study NCT ID:
NCT06540404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Knee Mobilisation on Joint Position Sense and Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2024-07-27', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint position sense', 'timeFrame': 'Before intervention and immediately after intervention', 'description': 'A passive-active test will be used to assess the joint position sense. The parameters will be measured angular position (degree of flexion) of the knee joint in the position passively set by the researcher and in the position actively recreated by the participant in both knee joints.'}], 'secondaryOutcomes': [{'measure': 'Biomechanical properties of knee joint tissues: Frequency', 'timeFrame': 'Before intervention and immediately after intervention', 'description': 'The values of knee joint tissue parameters will be assessed by using MyotonPro'}, {'measure': 'Biomechanical properties of knee joint tissues: Stiffness', 'timeFrame': 'Before intervention and immediately after intervention', 'description': 'The values of knee joint tissue parameters will be assessed by using MyotonPro'}, {'measure': 'Biomechanical properties of knee joint tissues: Relaxation', 'timeFrame': 'Before intervention and immediately after intervention', 'description': 'The values of knee joint tissue parameters will be assessed by using MyotonPro'}, {'measure': 'Biomechanical properties of knee joint tissues: Decrement', 'timeFrame': 'Before intervention and immediately after intervention', 'description': 'The values of knee joint tissue parameters will be assessed by using MyotonPro'}, {'measure': 'Biomechanical properties of knee joint tissues: Creep', 'timeFrame': 'Before intervention and immediately after intervention', 'description': 'The values of knee joint tissue parameters will be assessed by using MyotonPro'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee', 'manual therapy', 'healthy people', 'MyotonPRO'], 'conditions': ['Manual Therapy', 'Knee']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of traction mobilizations on position sense in the knee joint and on the biomechanical properties of the knee joint tissues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no lower extremity injuries within the past year,\n* no pain within the past seven days and on the day of the study,\n* feeling well on the day of the study,\n* no intense physical exertion on the day of the study,\n* no occurrence of delayed muscle pain on the day of the study and up to three days back.\n\nExclusion Criteria:\n\n* chronic diseases affecting motor skills,\n* lower extremity injuries occurring within a year and treated with a physiotherapist or physician,\n* complaints of pain or malaise on the day of the study,\n* knee pain within the last 7 days,\n* the occurrence of delayed muscle pain up to three days back,\n* participation in intense physical exertion on the day of the study.'}, 'identificationModule': {'nctId': 'NCT06540404', 'briefTitle': 'Effect of Knee Mobilisation on Joint Position Sense and Tissues', 'organization': {'class': 'OTHER', 'fullName': 'The Jerzy Kukuczka Academy of Physical Education in Katowice'}, 'officialTitle': 'Effects of Traction Mobilization Techniques on Knee Joint Position Sense and Biomechanical Properties of Knee Joint Tissues', 'orgStudyIdInfo': {'id': '3/01/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in this group did not undergo any therapy.'}, {'type': 'EXPERIMENTAL', 'label': 'Pulse traction group', 'description': 'Participants assigned to this group underwent second degree impulse traction of the knee joint according to the Kaltenborn concept.', 'interventionNames': ['Other: Pulse traction']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous traction group', 'description': 'Participants assigned to this group underwent continuous traction of the knee joint in the third degree according to the Kaltenborn concept.', 'interventionNames': ['Other: Continuous traction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham therapy group', 'description': 'The therapist did not use traction force, the knee joint was kept in a flexed position of 40 degrees.', 'interventionNames': ['Other: Sham therapy']}], 'interventions': [{'name': 'Pulse traction', 'type': 'OTHER', 'description': 'The subjects underwent impulse traction of the knee joint in the second degree according to the Kaltenborn concept.', 'armGroupLabels': ['Pulse traction group']}, {'name': 'Continuous traction', 'type': 'OTHER', 'description': 'The subjects underwent continuous traction of the knee joint in the third degree according to the Kaltenborn concept.', 'armGroupLabels': ['Continuous traction group']}, {'name': 'Sham therapy', 'type': 'OTHER', 'description': 'The therapist did not use traction force, the knee joint was kept in a flexed position of 40 degrees.', 'armGroupLabels': ['Sham therapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Katowice', 'country': 'Poland', 'facility': 'Motion Analysis Laboratory, The Jerzy Kukuczka Academy of Physical Education', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'overallOfficials': [{'name': 'Agnieszka Polaczek, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Jerzy Kukuczka Academy of Physical Education in Katowice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Master of Science', 'investigatorFullName': 'Polaczek Agnieszka', 'investigatorAffiliation': 'The Jerzy Kukuczka Academy of Physical Education in Katowice'}}}}