Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:09 PM
Study NCT ID:
NCT07405034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI Driven EX Versus Conventional in PFPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'All participants will randomized via random generator (www.randomization.com). All patients will be blinded to group allocation by ensuring that they will be unaware of the exercises performed by the other group. To maintain the blinding, the intervention sessions will be delivered separately to members of each treatment group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is randomized controlled trial and includes 40 participants .These participants divided into 2 groups (A, B), each group will be assessed with 3 measurments (vas ,dynamic knee valgus, Kujala Anterior Knee Pain Scale) and each group will receive difeerent treatments.\n\nThe individuals in group A(study group) will preceive AI driven exercises program while the individual in group B will receive conventional exercises therapy program. Participants in the both groups are prescribed a 6-week comprehensive exercises program (3 sessions per week) day after day and assessment procedure will be performed pre and post treatmeant .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kujala Anterior Knee Pain Scale', 'timeFrame': 'up to 6 weeks', 'description': 'a 13-item scale assessing knee functionality. The total Kujala score ranges from 0 to 100, with higher values indicating better performance. Additionally, The Kujala score is known for its reliability and validity in assessing patients with frozen PFPS'}], 'secondaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': 'up to 6 weeks', 'description': 'Pain intensity is assessed using the visual analog scale. Participants are instructed to indicate their pain level on a line ranging from 0 to 10, with 0 representing no pain and 10 indicating unbearable pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patello Femoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate and compare the effect of AI driven exercises program versus the conventional exercises therapy program on pain, function and dynamic knee valgus angle in treatment of patellofemoral pain syndrome.This study is randomized controlled trial and includes 40 participants .These participants divided into 2 groups (A, B), each group will be assessed with 3 measurments (vas ,dynamic knee valgus, Kujala Anterior Knee Pain Scale) and each group will receive difeerent treatments.\n\nThe individuals in group A(study group) will preceive AI driven exercises program while the individual in group B will receive conventional exercises therapy program. Participants in the both groups are prescribed a 6-week comprehensive exercises program (3 sessions per week) day after day and assessment procedure will be performed pre and post treatmeant .', 'detailedDescription': 'PURPOSE : This study aims to investigate and compare the effect of AI driven exercises program versus the conventional exercises therapy program on pain, function and dynamic knee valgus angle in treatment of patellofemoral pain syndrome.\n\nBACKGROUND:\n\nPatellofemoral pain syndrome (PFPS) is one of the most common knee problems that disturb function and daily activities (Menek et al .,2025). Symptoms of PFPS can develop either slowly or abruptly, and pain tends to worsen with activities such as squatting, prolonged sitting, stair climbing, jumping, or running (Menek et al .,2025). PFPS affects approximately 25% of physically active individuals (Smith et al .,2018).\n\nCore training significantly improves pain and functional limitations in patients with PFP and improves lower extremity motor performance to some extent (Y. Wang et al., 2024). These results draw more attention to the importance of the core muscle performance for both prevention and rehabilitation of the knee injuries\n\nHYPOTHESES:\n\nA-Primary Hypotheses:\n\nThis study will hypothesize that:\n\n1. There will be no significant effect of AI driven exercises program on pain in treatment of patients PFPS .\n2. There will be no significant effect of AI driven exercises program on function in treatment of patients PFPS .\n3. There will be no significant differences of AI driven exercises program and on dynamic knee valgus in treatment of patients PFPS.\n4. There will be no significant differences of conventional exercises therapy on pain in treatment of patients PFPS.\n5. There will be no significant differences of conventional exercises therapy on function in treatment of patients PFPS.\n6. There will be no significant differences of conventional exercises therapy dynamic knee valgus in treatment of patients PFPS.\n\nRESEARCH QUESTION:\n\nThis study will try to answer the following questions:\n\nThis study will try to answer:What are the effects of of AI driven exercises program and the conventional exercises therapy program on pain, function and dynamic knee valgus angle in treatment of patellofemoral pain syndrome ?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their ages range from 18- 40 years old, including both genders (male \\& female).\n* Their BMI will be ≤ 29 kg/m2.\n* A traumatic knee pain persisting for at least three months.\n\nExclusion Criteria:\n\n* Any congenital deformity of the lower limb,\n* Any recent injuries and surgeries\n* severe foot deformities such as hallux valgus and claw toe\n* Neuromuscular and neurological disorders.- history of patellofemoral dislocation, subluxation .'}, 'identificationModule': {'nctId': 'NCT07405034', 'acronym': 'AI- PFPS', 'briefTitle': 'AI Driven EX Versus Conventional in PFPS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Artificial Intelligence Driven Exercises Versus Conventional Exercises Therapy for Patellofemoral', 'orgStudyIdInfo': {'id': 'P.T.REC/012/006096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '( AI driven EX for study group )', 'description': 'The individuals in group A(study group) will preceive AI driven exercises program while the individual in group B will receive conventional exercises therapy program. Participants in the both groups are prescribed a 6-week comprehensive exercises program (3 sessions per week) day after day and assessment procedure will be performed pre and post treatmeant', 'interventionNames': ['Other: Ai driven EX']}, {'type': 'OTHER', 'label': 'conventional ex group', 'description': 'The individual in group B will receive conventional exercises therapy program. Participants in the both groups are prescribed a 6-week comprehensive exercises program (3 sessions per week) day after day and assessment procedure will be performed pre and post treatmeant .', 'interventionNames': ['Other: conventional exercises therapy program']}], 'interventions': [{'name': 'conventional exercises therapy program', 'type': 'OTHER', 'description': 'The individual in group B will receive conventional exercises therapy program. Participants are prescribed a 6-week comprehensive exercises program (3 sessions per week) day after day and assessment procedure will be performed pre and post treatmeant', 'armGroupLabels': ['conventional ex group']}, {'name': 'Ai driven EX', 'type': 'OTHER', 'description': 'The individuals in group A(study group) will preceive AI driven exercises program . Participants in the both groups are prescribed a 6-week comprehensive exercises program (3 sessions per week) day after day and assessment procedure will be performed pre and post treatmeant', 'armGroupLabels': ['( AI driven EX for study group )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'The Capital', 'country': 'Egypt', 'facility': 'the out-patient clinic faculty of physical therapy, Cairo University,', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Alaa hamdi rizk, master degree', 'role': 'CONTACT', 'email': 'alaa.potter35@gmail.com', 'phone': '+201023429731'}, {'name': 'DINA SAYED ABD ALLAH, lecturer of PT', 'role': 'CONTACT', 'email': 'drdinasayed_pt@yahoo.com', 'phone': '+2012 82742057', 'phoneExt': '+2012 82742057'}, {'name': 'Alaa Hamdi Rizk, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'the out-patient clinic faculty of physical therapy, Cairo University,', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Alaa Hamdi Rizk, master degree', 'role': 'CONTACT', 'email': 'alaa.potter35@gmail.com', 'phone': '+201023429731', 'phoneExt': '+201023429731'}, {'name': 'DINA SAYED ABD ALLAH, Lecturer of Physical Therapy', 'role': 'CONTACT', 'email': 'drdinasayed_pt@yahoo.com', 'phone': '+20 12 82742057', 'phoneExt': '+20 12 8274205'}], 'overallOfficials': [{'name': 'SALWA FADL abdelmegeed, Professor of Physical Therapy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is available with correspondig offer on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Alaa hamdi elsaid rizk', 'investigatorAffiliation': 'Cairo University'}}}}