Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07253467
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Load Dependent Modulation of Spinal Excitability: Linking H-Reflex Supression and Whole Body Vibration Induced Reflex Latency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole Body Vibration induced reflex latency', 'timeFrame': 'Day 1 (single-session, during each experimental condition)', 'description': 'WBV induced reflex latency will be measured'}, {'measure': 'H-Reflex Size', 'timeFrame': 'Day 1 (single-session, during each experimental condition)', 'description': 'Peak to peak amplitude of the H-Reflex will be measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['H-Reflex', 'Whole Body Vibration', 'Bone Myoregulation Reflex', 'Reflex Latency'], 'conditions': ['Vibration', 'H-reflex']}, 'descriptionModule': {'briefSummary': 'This study examines how different standing postures and whole-body vibration conditions affect spinal reflex activity. Participants will stand in various positions-with and without vibration of two amplitudes-and H-reflex responses from the soleus muscle will be recorded. Additionally, vibration-induced reflex latency will be assessed across multiple vibration frequencies.', 'detailedDescription': 'Participants will engage in a structured set of experimental tasks designed to evaluate the effects of postural mechanical loading, and whole-body vibration.\n\nThe protocol includes four primary standing conditions:\n\nQuiet bipedal stance,\n\nSingle-leg stance on the left side,\n\nBipedal stance during whole-body vibration (WBV), and\n\nSingle-leg stance on the left side during WBV.\n\nDuring all WBV conditions, two vibration amplitudes-2.2 mm and 1.2 mm-will be applied sequentially to assess amplitude-dependent modulation of reflex responses.\n\nThroughout each condition, H-reflex recordings from the soleus muscle will be collected to quantify changes in spinal reflex excitability under varying postural and vibratory loads. In addition to these measurements, vibration-induced reflex latency will be evaluated by delivering vibratory stimuli at multiple frequencies (30, 32, 34, and 36 Hz) within the same experimental protocol. This approach allows for a comprehensive analysis of how both posture and vibratory parameters influence neuromuscular reflex pathways.\n\nThe investigators conducted an a priori power analysis for a repeated-measures ANOVA (within-subjects design) to determine the required sample size. The analysis was based on a medium expected effect size, specified as partial eta squared (ηₚ²) = 0.06, which corresponds to an effect size of f = 0.25. The investigators set the alpha error probability at 0.05 and the desired statistical power (1-β) at 0.80. The design included one group with five repeated measurements, assuming a correlation of 0.70 among repeated measures. Under these conditions, the critical F value was 2.5652405, with 4 numerator degrees of freedom and 48 denominator degrees of freedom. The power analysis indicated that a total sample size of 13 participants is required. The required sample size was calculated using G\\*Power version 3.1.9.4 (Franz Faul, University of Kiel, Germany).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults between 25 and 50 years of age\n* Individuals willing to participate and able to provide informed consent\n* Individuals who can stand independently for at least 10 minutes\n* Participants with no known neurological, orthopedic, or balance impairments\n\nExclusion Criteria:\n\n* Individuals who can not tolerate WBV\n* Individuals who can not tolerate electrical stimulation\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07253467', 'acronym': 'SRML', 'briefTitle': 'Load Dependent Modulation of Spinal Excitability: Linking H-Reflex Supression and Whole Body Vibration Induced Reflex Latency', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Load Dependent Modulation of Spinal Excitability: Linking H-Reflex Supression and Whole Body Vibration Induced Reflex Latency', 'orgStudyIdInfo': {'id': 'IstPRMTRH2A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy participants', 'description': 'Participants will complete a series of experimental tasks involving postural mechanical and vibrational loading. The protocol consists of quiet standing on both feet, single-leg standing on the left side, standing during whole-body vibration (WBV), and single-leg standing on the left side during WBV. Vibration amplitudes of 2.2 mm and 1.2 mm will be applied in each condition. H-reflex measurements will be recorded from the soleus muscle throughout all tasks to evaluate alterations in spinal reflex excitability. Vibration induced reflex latency will be also measured with different vibration frequencies (30-32-34-36) also measured in the same protocol.', 'interventionNames': ['Other: Whole Body Vibration']}], 'interventions': [{'name': 'Whole Body Vibration', 'type': 'OTHER', 'description': 'Whole Body Vibration (WBV) is a neuromuscular training modality in which patients stand, sit, or exercise on a platform that delivers mechanical oscillations (30-36 Hz, 1-2 mm amplitude). While WBV is applied H-Reflex tests are done.', 'armGroupLabels': ['Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34158', 'city': 'Istanbul', 'state': 'Bahçelievler', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'İsmet Alkım Özkan', 'role': 'CONTACT', 'email': 'dr.alkimozkan@gmail.com', 'phone': '5356350591', 'phoneExt': '+90'}], 'facility': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'İsmet Alkım Özkan', 'role': 'CONTACT', 'email': 'dr.alkimozkan@gmail.com', 'phone': '5356350591', 'phoneExt': '+90'}, {'name': 'Ilhan Karacan', 'role': 'CONTACT', 'email': 'mdkaracanilhan@gmail.com', 'phone': '532700536', 'phoneExt': '+90'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'İsmet Alkım Özkan', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}