Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06131658
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Functional Motor Control on Pain, Flexibility, Lower Extremity Function With ITBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058745', 'term': 'Iliotibial Band Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'assessor who will take reading is blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric pain rating scale', 'timeFrame': 'pre and 6 weeks post interventional', 'description': 'pain will be assess by Numeric pain rating scale with minimum score 0 to maximum score 10'}, {'measure': 'flexibility', 'timeFrame': 'pre and 6 weeks post interventional', 'description': 'flexibility will be assess by Y balance'}, {'measure': 'lower extremity function', 'timeFrame': 'pre and 6 weeks post interventional', 'description': 'lower extremity function will be assess by lower limb extremity scale with score 0 to 80'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor control function excercise', 'lower extermity function', 'Iliotibial Band Syndrome'], 'conditions': ['Iliotibial Band Syndrome', 'Pain', 'Flexibility']}, 'referencesModule': {'references': [{'pmid': '16603885', 'type': 'BACKGROUND', 'citation': 'McKean KA, Manson NA, Stanish WD. Musculoskeletal injury in the masters runners. Clin J Sport Med. 2006 Mar;16(2):149-54. doi: 10.1097/00042752-200603000-00011.'}, {'pmid': '11916889', 'type': 'BACKGROUND', 'citation': 'Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.'}, {'pmid': '10959926', 'type': 'BACKGROUND', 'citation': 'Fredericson M, Cookingham CL, Chaudhari AM, Dowdell BC, Oestreicher N, Sahrmann SA. Hip abductor weakness in distance runners with iliotibial band syndrome. Clin J Sport Med. 2000 Jul;10(3):169-75. doi: 10.1097/00042752-200007000-00004.'}, {'pmid': '26616177', 'type': 'BACKGROUND', 'citation': 'Baker RL, Fredericson M. Iliotibial Band Syndrome in Runners: Biomechanical Implications and Exercise Interventions. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):53-77. doi: 10.1016/j.pmr.2015.08.001.'}, {'pmid': '17728030', 'type': 'BACKGROUND', 'citation': 'Noehren B, Davis I, Hamill J. ASB clinical biomechanics award winner 2006 prospective study of the biomechanical factors associated with iliotibial band syndrome. Clin Biomech (Bristol). 2007 Nov;22(9):951-6. doi: 10.1016/j.clinbiomech.2007.07.001. Epub 2007 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \\& B through sealed envelope method by non-probability convenient random sampling technique. Subjects in group A will receive functional motor control exercises. Group B will receive conventional exercises.', 'detailedDescription': "The objective of this study is to determine the effects of functional motor control exercises on pain, flexibility and lower limb functional. It will be randomized controlled trial (RCT) research design at Pakistan sports board through non probability convenience sampling technique on 72 runners' athletes which will be allocated using random sampling through computerized generated number into Group A and Group B, 36 athletes will be in each group. Group A (interventional) will be given conventional training with functional motor exercise and Group B (control) will be given conventional training. There will be 3 sessions in a week for 6 weeks. The baseline scoring will be on 1st day, follow up will be taken at 6th week. Assessment will be made by Numeric pain rating scale, Lower extremity functional scale (LEFS), Single leg mini squat, Y balance. Data will be analyzed during SPSS software version 26. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two group"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male and female athlete within 19-40 years,\n* running a minimum average of 15 running kilometers,\n* Runners with one sided iliotibial band syndrome for at least 3 months were included,\n* Pain along IT band at either Gerdy's tubercle or the lateral femoral epicondyle during running,\n* positive stiffness with Ober's test, and\n* reporting pain during Noble's compression test.\n\nExclusion Criteria:\n\n* Individuals with a history of previous knee trauma of past 6 months,\n* Individuals with a history of previous knee surgery of past 6 months,\n* Other knee abnormalities including patellofemoral joint pain,\n* popliteus tendinitis,\n* lateral meniscal injury,\n* Degenerative joint disease, and\n* lateral collateral ligament sprain to the affected side."}, 'identificationModule': {'nctId': 'NCT06131658', 'briefTitle': 'Effects of Functional Motor Control on Pain, Flexibility, Lower Extremity Function With ITBS', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Functional Motor Control Exercise on Pain, Flexibility, Lower Extremity Function Among Runners With Iliotibial Band Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional motor control excercise', 'description': 'Functional motor control exercise Includes side plank with clamshell, Side plank with hip abduction, Side-lying hip abduction, Lateral monster walk, Hip hikes, Single leg squat, TKE with T-band-hip abduction All exercises done with 2 sets of 10 reps with 3 sessions per week for 6 weeks', 'interventionNames': ['Other: Functional motor control excercise']}, {'type': 'EXPERIMENTAL', 'label': 'conventional exercise', 'description': 'The conventional exercise included 4 stages of self-myofascial techniques, strengthening, and integration techniques. In the first phase, individuals did fascial release exercises using foam rolls, focusing on tensor fascia latae, iliotibial band, and hip adductor muscles, and tennis balls for the quadratus lumborum. The exercises were performed at high-intensity maximum pain tolerance for 30 seconds or low-intensity minimum pain tolerance for 90 seconds.', 'interventionNames': ['Other: convectional excercise']}], 'interventions': [{'name': 'Functional motor control excercise', 'type': 'OTHER', 'description': 'This include functional motor control thrice a week for six weeks', 'armGroupLabels': ['Functional motor control excercise']}, {'name': 'convectional excercise', 'type': 'OTHER', 'description': 'This include convectional exercise thrice a week for six weeks', 'armGroupLabels': ['conventional exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37700', 'city': 'Faisalābad', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'hamza ali, MBA', 'role': 'CONTACT', 'email': 'hamza.azeem2018@gmail.com', 'phone': '+92-3020160361'}, {'name': 'Maham Athar, DPT', 'role': 'CONTACT', 'email': 'mahamathar666@gmail.com', 'phone': '03356600213', 'phoneExt': 'Athar'}, {'name': 'Maham Athar, DPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'amna shahid, MS-DPT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jawad Club'}], 'centralContacts': [{'name': 'Amna Shahid, MS-DPT', 'role': 'CONTACT', 'email': 'amna.shahid@riphah.edu.pk', 'phone': '+92 334 4512823'}], 'overallOfficials': [{'name': 'maham Athar, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}