Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT07210060
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Knee Strengthening With Hip vs. Ankle Exercises in Women 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010208', 'term': 'Papaverine'}], 'ancestors': [{'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-25', 'size': 422585, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-26T02:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single Leg Landing Task', 'timeFrame': '2 minute', 'description': "The participant stood on a 30 cm box and first bent the non-testing leg's knee to approximately 90 degrees. After stabilizing, the participant jumped forward with the testing leg to a target 10 cm away from the box, maintaining balance for five seconds upon landing."}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Rating Scale', 'timeFrame': '1 minute', 'description': '0 indicates no pain and 10 indicates the worst pain imaginable.'}, {'measure': 'Patellar Tendon Stiffness Measurement', 'timeFrame': '3 minute', 'description': 'The stiffness of the patellar tendon was assessed using a handheld device (MyotonPRO; Tallinn, Estonia).'}, {'measure': 'Muscle structure', 'timeFrame': '15 minute', 'description': 'A portable ultrasound device (Linear wireless probe LU700L VET) was used to assess the structure of the gastrocnemius and gluteus medius muscles in a resting state.'}, {'measure': 'Ankle Joint ROM', 'timeFrame': '3 minute', 'description': 'used a weight-bearing lunge test to measure the active dorsiflexion angle of the ankle during weight-bearing.'}, {'measure': 'Maximum Voluntary Isometric Strength', 'timeFrame': '15 minute', 'description': 'A handheld dynamometer (MicroFET3; Hoggan Scientific LLC, USA) was used to measure the maximum isometric strength of the hip abductors, knee extensors, ankle dorsiflexors, and ankle plantar flexors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dynamic alignment', 'Tele-rehabilitation', 'Pain modulation', 'Muscle strength'], 'conditions': ['Patellofemoral Pain Syndrome', 'Anterior Knee Pain', 'Exercise Therapy']}, 'descriptionModule': {'briefSummary': 'Eight weeks of telehealth-based supervised exercise effectively reduced DKV and pain in women with anterior knee pain. Both intervention groups demonstrated comparable benefits.', 'detailedDescription': 'This study compared the effects of knee strengthening combined with either hip or ankle joint exercises on dynamic knee valgus (DKV), visual analogue scale (VAS) scores during activity, tendon stiffness, muscle structure, ankle range of motion, and muscle strength in women with anterior knee pain. Forty-five female recreational athletes aged 20-40 with anterior knee pain were randomly assigned to three groups: hip + knee exercises (HK group, n = 15), ankle + knee exercises (AK group, n = 15), and stretching alone (control group, n = 15). The HK and AK groups received supervised telehealth-based exercise sessions (30 minutes/day, 3 times/week for 8 weeks), while the control group received only an educational pamphlet. Assessments were conducted at baseline, 4 weeks, and 8 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female recreational athletes aged 20-40 years who engage in regular exercise\n2. Experiencing pain in the anterior or surrounding patella during at least two or more of the following activities: walking, running, jumping, kneeling, squatting, climbing stairs, or prolonged sitting\n3. A pain index of 3 or higher on the Numeric Pain Rating Scale (NPRS) and symptoms persisting for at least 3 months\n4. Knee pain unrelated to trauma.\n\nExclusion Criteria:\n\n1. Inability to operate a smartphone or computer\n2. History of fractures or surgeries involving the hip, knee, ankle, or foot\n3. History of meniscus, knee ligament injuries, or ankle sprains within the last six months\n4. Knee ligament laxity, inflammation, swelling, patellar dislocation, or subluxation\n5. Cognitive impairment or inability to follow simple instructions\n6. History of cardiovascular or neurological disorders\n7. Advised by a physician to avoid exercise. Use of over-the-counter pain medication was not an exclusion criterion.'}, 'identificationModule': {'nctId': 'NCT07210060', 'briefTitle': 'Knee Strengthening With Hip vs. Ankle Exercises in Women With Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Comparison of Knee Strengthening Combined With Hip or Ankle Joint Exercises on Clinical Symptoms, Sports Performance and Soft Tissue Structure in Women With Patellofemoral Pain Syndrome', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20220334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HK group', 'description': 'hip + knee joint exercise group', 'interventionNames': ['Other: hip + knee joint exercise group']}, {'type': 'EXPERIMENTAL', 'label': 'AK group', 'description': 'ankle + knee joint exercise group', 'interventionNames': ['Other: ankle + knee joint exercise group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Stretching group', 'description': 'Stretching group', 'interventionNames': ['Other: Stretching group']}], 'interventions': [{'name': 'hip + knee joint exercise group', 'type': 'OTHER', 'description': 'Hip: squat, glute bridge and gluteus medius exercise Knee: knee flexor and extensor, isometric squat hold', 'armGroupLabels': ['HK group']}, {'name': 'ankle + knee joint exercise group', 'type': 'OTHER', 'description': 'Knee: knee flexor and extensor, isometric squat hold Ankle: plantar flexor, dorsi flexor and lunge', 'armGroupLabels': ['AK group']}, {'name': 'Stretching group', 'type': 'OTHER', 'description': 'Education Handout on Lower Limb Stretching', 'armGroupLabels': ['Stretching group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Tainan', 'state': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Nai-Jen Chang', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}