Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 5:06 AM
Study NCT ID:
NCT07025434
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hip Bump Manipulation Versus Sham Treatment in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-Arm Parallel Group Randomized Controlled Trial (RCT) Group A: Intervention Group B: Control (Sham)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip External Rotation Strength', 'timeFrame': '"From pre-intervention to post-intervention within a single session lasting approximately 20 minutes."', 'description': 'Measured with ActivForce Handheld Dynamometry. 3 trials for an average Mean Voluntary Isometric Contraction'}, {'measure': 'Hip Internal Rotation Range of Motion', 'timeFrame': '"From pre-intervention to post-intervention within a single session lasting approximately 20 minutes."', 'description': 'Hip Internal rotation measured in a seat position 90/90 position. Measured with IPhone Digital Goniometry. 3 trials with a calculated average'}, {'measure': 'Hip EMG Muscle Activation', 'timeFrame': '"From pre-intervention to post-intervention within a single session lasting approximately 20 minutes."', 'description': 'Delsys Trigno Wireless System will be used to monitor changes in muscle activation between the Tensor Fascia Latae, Gluteus Medius, and Gluteus Maximus. During seated isometric external rotation contraction and bipodal landing. EMG will be retrieved on the 2nd attempt out of 3 trials.'}, {'measure': 'Bipodal Landing', 'timeFrame': '"From pre-intervention to post-intervention within a single session lasting approximately 20 minutes."', 'description': 'Kinvent K-Delta Force Plates used to measure changes in bipodal landing mechanics including force distribution, time to stabilization, etc. 3 trials will be conducted to present average values'}], 'secondaryOutcomes': [{'measure': 'Hip Deviation with Active Assisted Hip Flexion Range of Motion', 'timeFrame': '"From pre-intervention to post-intervention within a single session lasting approximately 20 minutes."', 'description': 'Deviation resulting in excessive abduction and external rotation during knee to chest active assisted range of motion. Video recording before and after to observe changes pre and post intervention.'}, {'measure': 'Hip External Rotation Range of Motion', 'timeFrame': '"From pre-intervention to post-intervention within a single session lasting approximately 20 minutes."', 'description': 'Measured to compare the change in External and Internal Rotation range of motion relationship. Measure with iPhone Digital Goniometry. 3 trials will be conducted to present an average value of ROM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Bump Manipulation', 'Unrestrained Femoral Internal Rotation', 'UFIR', 'HVLAT'], 'conditions': ['Assessment of Hip Strength, Range of Motion, EMG Activation, and Landing Mechanics in Healthy Subjects', 'Healthy Adult Subjects']}, 'referencesModule': {'references': [{'pmid': '29287067', 'type': 'BACKGROUND', 'citation': 'van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.'}, {'pmid': '35197646', 'type': 'BACKGROUND', 'citation': 'Kazemi M, Leguard SH, Lilja S, Mahaise S. A clinical crossover trial of the effect of manipulative therapy on pain and passive and active range of motion of the painful hip. J Can Chiropr Assoc. 2021 Dec;65(3):318-329.'}, {'pmid': '28900559', 'type': 'BACKGROUND', 'citation': 'Bazett-Jones DM, Tylinksi T, Krstic J, Stromquist A, Sparks J. PEAK HIP MUSCLE TORQUE MEASUREMENTS ARE INFLUENCED BY SAGITTAL PLANE HIP POSITION. Int J Sports Phys Ther. 2017 Aug;12(4):535-542.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1186/s12891-024-07463-5', 'label': 'Related Info'}, {'url': 'https://doi.org/10.55225/hppa.548', 'label': 'Related Info'}, {'url': 'https://doi.org/10.26603/001c.35577', 'label': 'Related Info'}, {'url': 'https://www.ncbi.nlm.nih.gov/books/NBK574527/', 'label': 'Related Info'}, {'url': 'https://doi.org/10.26603/001c.89261', 'label': 'Related Info'}, {'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC5638457/', 'label': 'Related Info'}, {'url': 'https://doi.org/10.1016/j.jelekin.2020.102457', 'label': 'Related Info'}, {'url': 'https://doi.org/10.1371/journal.pone.0189876', 'label': 'Related Info'}, {'url': 'https://scholars.indianastate.edu/clinat/vol7/iss3/33/', 'label': 'Related Info'}, {'url': 'https://journals.humankinetics.com/view/journals/jsr/32/7/article-p810.xml', 'label': 'Related Info'}, {'url': 'https://doi.org/10.1016/j.math.2016.10.013', 'label': 'Related Info'}, {'url': 'https://doi.org/10.1371/journal.pone.0230841', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to objectively assess the effects of hip bump manipulation (HBM) on a healthy population aged 18-45 years. We hypothesize that the HBM will improve hip internal rotation passive range of motion, improve the strength of the hip external rotators, decrease compensatory motions in hip flexion during active range of motion, and improve bipodal landing mechanics.\n\nHuman participants will be analyzed to determine whether the manipulation produces the intended clinical outcomes. While clinicians commonly use this technique, its effectiveness has yet to be substantiated through research. This technique is a high velocity low amplitude thrust to the greater trochanter which theorizes the quick stretch of the external rotator muscles and may improve a malpositioned femoral head within the acetabulum. These improvements may positively affect functional movements such as bipodal landing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals\n* Aged 18-45 years old\n\nExclusion Criteria:\n\n* Diagnosed demoroacetabular labral tear\n* Diagnosed osteoarthritis (OA)\n* Current or recent (within the past 6 months) low back pain\n* Hip or pelvic pain\n* Lower extremity injury within the past six months\n* Diagnosed scoliosis\n* History of surgery involving the femoroacetabular joint (FAJ)\n* Known allergic reaction to adhesive or shaving cream used for EMG placement'}, 'identificationModule': {'nctId': 'NCT07025434', 'briefTitle': 'Effects of Hip Bump Manipulation Versus Sham Treatment in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Dominican University New York'}, 'officialTitle': 'Effects of Hip Bump Manipulation Versus Sham Treatment on Hip Internal Rotation, External Rotator Strength, and Bipodal Landing in Healthy Adults Aged 18-45: A Single-Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-0328-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Intervention', 'description': 'Hip Bump Manipulation (UFIR)', 'interventionNames': ['Procedure: Hip Bump Manipulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group B: Control', 'description': 'Iliac Crest Bump Sham Manipulation', 'interventionNames': ['Procedure: Sham (No Treatment)']}], 'interventions': [{'name': 'Hip Bump Manipulation', 'type': 'PROCEDURE', 'otherNames': ['UFIR', 'Unrestrained Femoral Internal Rotation'], 'description': 'This technique is a high velocity low amplitude thrust (HVLAT) directly posterior to the greater trochanter which theorizes the quick stretch of the external rotator muscles and may improve a malpositioned femoral head within the acetabulum.', 'armGroupLabels': ['Group A: Intervention']}, {'name': 'Sham (No Treatment)', 'type': 'PROCEDURE', 'description': 'Iliac Crest Sham Manipulation', 'armGroupLabels': ['Group B: Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10962', 'city': 'Orangeburg', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ayse Edeer, B.S, M.S, Ph.D.', 'role': 'CONTACT', 'email': 'ayse.edeer@duny.edu', 'phone': '(845) 848-7615'}, {'name': 'Karl Rusch, B.S., DSc, DPT', 'role': 'CONTACT', 'email': 'karl.rusch@duny.edu', 'phone': '(845) 848-6046'}, {'name': 'Joseph Almonte', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anthony Criscione', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tyler Riddick', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Derek Szuba', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dominican University New York', 'geoPoint': {'lat': 41.04649, 'lon': -73.94958}}], 'centralContacts': [{'name': 'Karl Rusch, B.S., DSc, DPT', 'role': 'CONTACT', 'email': 'karl.rusch@duny.edu', 'phone': '(845) 848-6046'}, {'name': 'Stephen Rodriguez, B.S., DSc, MPS PT, DPT', 'role': 'CONTACT', 'email': 'stephen.rodriguez@duny.edu', 'phone': '(845) 848-6047'}], 'overallOfficials': [{'name': 'Ayse Edeer, B.S., M.S., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dominican University New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified individual participant data, including demographic information and outcome measures, will be made publicly available as part of the research publication. All personal identifiers will be removed, and any video recordings of movement deviations will either not be shared or will have faces obscured to maintain participant privacy. Data will be provided in a format consistent with ethical guidelines and institutional requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dominican University New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}