Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-30 @ 8:20 AM
Study NCT ID:
NCT06958757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Effectiveness of Ankle Dorsiflexion Range of Motion Training in Patients With Patellofemoral Joint Pain.
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-04-19', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kujala Anterior Knee Pain Scale', 'timeFrame': 'Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).'}, {'measure': 'Ankle dorsiflexion range of motion', 'timeFrame': 'Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).'}], 'secondaryOutcomes': [{'measure': 'sEMG co-contraction ratios', 'timeFrame': 'All outcome measures (sEMG co-contraction) ratios are assessed at baseline (pre-intervention) and immediately after completing the 8-week intervention program (post-intervention).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patellofemoral Pain, PFP']}, 'descriptionModule': {'briefSummary': 'Patellofemoral Pain (PFP) is a common knee condition causing pain around the kneecap during activities like running or squatting. Limited ankle flexibility ("dorsiflexion" - how far participants can lift their toes toward the shin) may worsen PFP by altering leg movements. This study investigates whether adding ankle flexibility exercises to standard knee-strengthening programs improves outcomes for young adults with PFP. Active adults aged 18-30 with PFP and limited ankle flexibility (measured with a simple tool) are eligible, excluding those with prior knee/ankle surgeries, fractures, or conditions like arthritis. Sixty-four participants will be randomly assigned to either an Exercise + Ankle Training group (standard knee exercises plus targeted ankle training) or an Exercise-Only group for 8 weeks under physiotherapist guidance. Outcomes include improvements in knee pain scores (Kujala Scale), ankle flexibility changes, and muscle coordination measured with non-invasive sensors. If effective, ankle flexibility training could provide a low-cost addition to current treatments, helping patients resume activities with less pain. The study follows international ethical guidelines and has received preliminary ethics approval (No. TJUS-2025-054).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-30 years\n* Diagnosed with patellofemoral pain (PFP) per clinical guidelines (anterior knee pain aggravated by ≥2 activities: running, squatting, stair climbing)\n* Ankle dorsiflexion range of motion (ROM) \\<10° (measured via goniometer in weight-bearing)\n* BMI 18.5-28 kg/m²\n* Engage in regular physical activity (≥3 sessions/week)\n\nExclusion Criteria:\n\n* Ankle fractures\n* Achilles tendon rupture\n* Rheumatoid arthritis\n* Gout, or systemic diseases\n* Prior knee/ankle surgeries\n* Concurrent lower limb injuries (e.g., ligament tears, meniscal pathology)\n* Neurological disorders affecting mobility\n* Participation in other lower limb rehabilitation programs within 3 months'}, 'identificationModule': {'nctId': 'NCT06958757', 'briefTitle': 'A Study on the Effectiveness of Ankle Dorsiflexion Range of Motion Training in Patients With Patellofemoral Joint Pain.', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin University of Sport'}, 'officialTitle': 'This RCT Included 64 Participants (18-30y) With PFP, Ankle Dorsiflexion ROM <10°, and BMI 18.5-28 kg/m². Exclusions: Ankle Fractures, Achilles Rupture, Rheumatoid Arthritis, Gout, Systemic Diseases, or Prior Knee/Ankle Surgeries. Randomized to Two Groups (n=32/Group): Experimental (Standard Exercise + Ankle Dorsiflexion Training) vs Control (Standard Exercise Only) at Matched Intensity/Frequency for 8 Weeks. Outcomes: VAS Pain, Kujala Scale, Ankle Dorsiflexion ROM. Certified Physiotherapists Supervise Sessions. Data Analyzed With SPSS 26.0. The Protocol Complies With the Helsinki Declaration.', 'orgStudyIdInfo': {'id': 'TJUS2025-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'standard exercise + ankle dorsiflexion training', 'interventionNames': ['Other: Standard Exercise Therapy + Ankle Dorsiflexion Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'standard exercise only', 'interventionNames': ['Other: Standard Exercise Therapy Only']}], 'interventions': [{'name': 'Standard Exercise Therapy + Ankle Dorsiflexion Training', 'type': 'OTHER', 'description': 'The experimental group receives:\n\nStandard Exercise Therapy (30 min/session, 3x/week for 8 weeks): Quadriceps eccentric exercises (e.g., slow step-downs), Hip abductor strengthening (e.g., side-lying leg lifts), and Neuromuscular control drills (e.g., single-leg balance on unstable surfaces).\n\nAnkle Dorsiflexion Training (15 min/session, 3x/week for 8 weeks): Mobilization techniques (posterior glides of the talus), Resistance band exercises (dorsiflexion against elastic bands), Progressive Achilles tendon stretching (weight-bearing calf stretches).\n\nExercise progression (resistance/intensity) is adjusted biweekly based on functional assessments.', 'armGroupLabels': ['experimental group']}, {'name': 'Standard Exercise Therapy Only', 'type': 'OTHER', 'description': 'Standard Exercise Therapy (30 min/session, 3x/week for 8 weeks): Quadriceps eccentric exercises (e.g., slow step-downs), Hip abductor strengthening (e.g., side-lying leg lifts), and Neuromuscular control drills (e.g., single-leg balance on unstable surfaces).\n\nExercise progression (resistance/intensity) is adjusted biweekly based on functional assessments.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yuan wu', 'role': 'CONTACT', 'email': '15750642556@163.com', 'phone': '+8615750642556'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin University of Sport', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wu Yuan', 'investigatorAffiliation': 'Tianjin University of Sport'}}}}