Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05441332
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2022-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of rotation', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space'}], 'secondaryOutcomes': [{'measure': 'Length measures', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'EOS femoro-tibial alignment'}, {'measure': 'Q angle (in degree)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'EOS femoro-tibial alignment'}, {'measure': 'Varus valgus(in degree)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'EOS femoro-tibial alignment'}, {'measure': 'Peak torque (N.m)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Quadriceps isokinetic strenght'}, {'measure': 'Total work (N.m)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Quadriceps isokinetic strenght'}, {'measure': 'Peak torque (N.m)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Hamstrings isokinetic strenght'}, {'measure': 'Total work (N.m)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Hamstrings isokinetic strenght'}, {'measure': 'Quadriceps/Hamstring ratio : 2 measure/leg', 'timeFrame': 'Day of inclusion (up to 10 days)'}, {'measure': 'Peak torque (N.m)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Hip abductors static strenght'}, {'measure': 'Average torque (N.m)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Hip abductors static strenght'}, {'measure': 'Time for reaching peak (s)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Hip abductors static strenght'}, {'measure': 'Time difference in the onset between the m.vastus lateralis and m.vastus medialis contraction in ms', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': "Activity of the quadriceps measured. Electromyogram was used to quantify the electric potential of quadriceps and referred to as 'quadriceps muscle EMG activity' throughout"}, {'measure': 'Y test', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Static and dynamic unipodal balance'}, {'measure': 'Eccentric step-down test', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Static and dynamic unipodal balance'}, {'measure': 'Lateral step down test', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Static and dynamic unipodal balance'}, {'measure': 'Unipodal stabilometric evaluation', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Static and dynamic unipodal balance'}, {'measure': 'Foot posture index', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Foot static'}, {'measure': 'Navicular drop test', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Foot static'}, {'measure': "Ober's test", 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Muscle hypoextensibility. Quadriceps, harmstrings, calves,'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Determine pain / No pain = 0, maximal pain =100'}, {'measure': 'Anterior knee pain scale (AKPS)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Questionnaire to determine pain / 13 questions, minimum score = 0 point, maximum score = 100 points'}, {'measure': '12-Item Short Form Survey (SF-12)', 'timeFrame': 'Day of inclusion (up to 10 days)', 'description': 'Quality of life, to determine pain'}, {'measure': 'Semi-structured interview', 'timeFrame': 'From month 1 to month 3', 'description': 'Semi-structured interview for a sub-group of 15 patients identify factors influencing patient adherence behavior.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patellofemoral pain syndrome', '3D Kinematics', 'assessment', 'clinical phenotypes', 'dynamic deficiencies'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe and compare the kinematic deficiencies specifically associated with each of the 3 main clinical phenotypes of patellofemoral pain syndrome. The prevalence of patellofemoral pain is high with a high rate of chronicity and recurrence and an overrepresentation of young, athletic and female populations. There are multiple classifications of patellofemoral pain syndrome. A pragmatic classification distinguishes 3 main clinical phenotypes of patellofemoral pain syndrome: with objectively displaceable patella, with extra-patellar alignment problems and without alignment problems.\n\nThe pathophysiology of patellofemoral pain syndrome is multifactorial involving static and dynamic dysfunctions of the hip, knee and foot, which remain incompletely elucidated to date. The links between the clinical and biomechanical aspects are still unclear and the kinematic and neuromuscular deficiencies associated with the 3 main clinical phenotypes are poorly understood. A validated non-invasive device allows the 3D evaluation of femorotibial rotations during walking.', 'detailedDescription': "The diagnostic process is based on clinical examination. The evolution of measuring tools like radios, RMI and kinematics device allows a more precise diagnostic of patellofemoral Pain syndrome. We still don't know what kind of gait parameters could help to categorize the different phenotypes. With a better understanding of these phenotypes the investigators will be able to propose a better personalized rehabilitation.\n\nPatellofemoral pain syndrome is defined as an anterior knee pain in front of and around the patella. The diagnosis of patellofemoral pain syndrome is based on clinical examination and standard imaging.\n\nThe pathophysiology of the patellofemoral pain syndrome is multifactorial involving static and dynamic dysfunctions of the hip, knee and foot, which remain incompletely elucidated to date. The prevalence of patellofemoral pain is high with a high rate of chronicity and recurrence and an overrepresentation of young, athletic and female populations. A pragmatic classification distinguishes 3 main clinical phenotypes of patellofemoral pain syndrome: with objectively displaceable patella, with extra-patellar alignment problems and without alignment problems.\n\nThe links between the clinic and biomechanics are still unclear and the kinematics and neuromuscular impairments associated with the 3 main clinical phenotypes are poorly understood.\n\nThe KneeKG is an optoelectronic kinematic assessment device using non-invasive sensors and dedicated to real-time measurement of 3D femoro-tibial position and rotations. The kinematic, neuro-muscular, postural and proprioceptive assessments will allow us to better understand the pathophysiology of the patellofemoral pain syndrome, to establish a more accurate diagnosis of the disease, and provide a better understanding of its causes.\n\nSeveral studies have shown that better adherence to exercise is associated with greater benefit in terms of pain and function in chronic pathologies.\n\nSemi-structured interviews will enable the investigators to assess the impact of information derived from kinematic examination of the knees on adherence to treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical diagnosis of SDFP :\n* Anterior pain of the knee, mechanical, in front of and around the patella noted at more than 3/10 on a simple numerical scale (ligament or meniscal damage, synovial plicae, tendinopathies, apophysitis, neuromas, and osteoarthritis FT are differential diagnoses),\n* Pain during any of the following activities: Going up / down stairs, squats, jumps, jogging, sitting, crouching.\n* Duration of knee anterior pain greater than 1 month\n* Affiliation to a social insurance\n* Signature of the consent to participate\n\nExclusion Criteria:\n\n* Neurological disorders affecting the lower extremities\n* Radiographic FT osteoarthritis\n* History of surgery or trauma to the lower limb less than 1 year old\n* Intra-articular knee infiltration ≤ 2 months\n* Cognitive or behavioral problems making it impossible to assess\n* Participates in intervention research or is in the exclusion period following a previous research, if applicable\n* Unable to speak, read and write French\n* Patients under guardianship or curatorship,\n* Patients receiving AME (French State Medical aid)'}, 'identificationModule': {'nctId': 'NCT05441332', 'acronym': 'PHENOPAT', 'briefTitle': 'Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Kinematic and Neuromuscular Deficiencies Phenotypes Associated With Patellofemoral Pain Syndrome : a Cross-sectional Interventional Study', 'orgStudyIdInfo': {'id': 'APHP211433'}, 'secondaryIdInfos': [{'id': '2021-A01928-33', 'type': 'OTHER', 'domain': 'France : Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patellofemoral pain syndrome', 'description': 'Kinematic and neuromuscular assessment', 'interventionNames': ['Other: EOS Radiation', 'Behavioral: Semi-structured interview']}], 'interventions': [{'name': 'EOS Radiation', 'type': 'OTHER', 'otherNames': ['EOS X-ray exams'], 'description': 'One EOS exam of lower extremities', 'armGroupLabels': ['Patellofemoral pain syndrome']}, {'name': 'Semi-structured interview', 'type': 'BEHAVIORAL', 'description': 'Semi-structured interview to identify factors influencing patient adherence behavior for a sub-group of 15 patients. By phone, between 1 to 3 months after inclusion.', 'armGroupLabels': ['Patellofemoral pain syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': "Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - Hôpital Cochin", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marvin COLEMAN, MSc, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}