Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-04 @ 8:28 AM
Study NCT ID:
NCT01631604
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Characteristics Following a Fall
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000074403', 'term': 'Meniscectomy'}, {'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}, {'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}, {'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait kinematics', 'description': 'Joint angles, velocities and accelerations'}], 'secondaryOutcomes': [{'measure': 'Muscle activation patterns', 'description': 'Dynamic EMG of various muscles.'}]}, 'conditionsModule': {'keywords': ['risk of falling', 'gait patterns', 'muscle activity', 'fall prevention', 'motor impairment'], 'conditions': ['Motor Impairments', 'Orthopaedic Injuries', 'Neurological Conditions']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.", 'detailedDescription': "In this study, patients suffering from motor disabilities as a result of orthopedic or neurologic impairments will be tested at the gait and motion laboratory. Each patient will be secured with a ceiling-mounted safety harness and will walk on the path wearing passive light-reflecting markers and surface electrodes. High-speed cameras will record the subject's movements and the markers will be tracked to produce data of joint angles, velocities and accelerations. Dynamic EMG will be recorded from various muscles.\n\nDuring the examination, the gait of the subjects will be disturb by either (i) a visual or sound signal that requires the subject to stop immediately, or (ii) walking different terrains, or (iii) tying a string to the foot and pulling it shortly to induce a trip."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.\n\nExclusion Criteria:\n\n* Subjects who are unable to understand and independently sign a consent form\n* Subjects who are wheelchair bound.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT01631604', 'briefTitle': 'Gait Characteristics Following a Fall', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Quantification of Gait Parameters and Muscle Activation Patterns Following a Fall', 'orgStudyIdInfo': {'id': 'Fall-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Walking aids and devices', 'type': 'DEVICE', 'description': 'Walking aids, e.g. braces, canes,orthoses, prosthetics, etc.'}, {'name': 'Muscle/nerve injection', 'type': 'DRUG', 'otherNames': ['Botulinum toxin', 'Marcaine'], 'description': 'Injection to muscle or nerve'}, {'name': 'Corrective surgery', 'type': 'PROCEDURE', 'otherNames': ['Knee arthroscopy, meniscectomy and chondroplasty', 'Anterior cruciate ligament reconstruction', 'Knee replacement', 'Repair of femoral neck fracture', 'Repair of trochanteric fracture', 'Debridement of skin/muscle/bone/fracture', 'Knee arthroscopy repair of both menisci', 'Hip replacement', 'Repair of ankle fracture (bimalleolar type)', 'Lumbar spinal fusion', 'Low back intervertebral disc surgery', 'Repair of femoral shaft fracture'], 'description': 'correction of spinal and bony deformities, muscle transfer, tendon elongation etc.'}, {'name': 'Physical therapy treatment', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91240', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}