Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 4:45 AM
Study NCT ID:
NCT00476333
Status:
UNKNOWN
Last Update Posted:
2007-05-22
First Post:
2007-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Healthy Subjects
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'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-05-21', 'studyFirstSubmitDate': '2007-05-19', 'studyFirstSubmitQcDate': '2007-05-21', 'lastUpdatePostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EMG', 'Kinetics', 'Kinematics', 'Perturbation', 'Footwear'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Introduction: Kinetic, kinematic and electromyographic activity of the lower limb have been shown to be influenced by various footwear-generated biomechanical manipulations (e.g. soles. Insoles, orthoses). A novel biomechanical device comprising four modular elements attached onto foot-worn platforms was recently developed. Each element can be individually calibrated (Position, convexity, height and resilience) to induce a specific biomechanical challenge.\n\nObjectives: The aim of this study is to evaluate the influence of specific biomechanical challenges on Kinetics, kinematics and electromyographic activity of the lower limb.\n\nDesign: Prospective, case control Setting: Motion analyses will be conducted during level walking with (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 16 different settings of the biomechanical system'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Similar anthorpometric profile (i.e. weight, shoe size, height, dominant leg)\n\nExclusion Criteria:\n\n* Previous orthopedic, musculosceletal or neurological pathology'}, 'identificationModule': {'nctId': 'NCT00476333', 'briefTitle': 'The Effect of Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Healthy Subjects', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'orgStudyIdInfo': {'id': '70/07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'APOS biomechanical gait system', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amir A Haim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alon Wolf, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nahum Halperin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Technion Israel institute of technology, Biomechanical and bio-robotics division gait laboratory', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Amir A Haim, MD', 'role': 'CONTACT', 'email': 'amirhaim@tx.technion.ac.il', 'phone': '+972-52-4373010'}, {'name': 'Alon Wolf, PhD', 'role': 'CONTACT', 'email': 'Alonw@tx.technion.ac.il', 'phone': '+972-52-6370434'}], 'overallOfficials': [{'name': 'Nahum Halperin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf-Harofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}}}}