Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 8:12 AM
Study NCT ID:
NCT03813004
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults
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': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motek Grail output (joint angles)', 'timeFrame': '40 minutes', 'description': 'Joint angles calculated using HBM Gait model \\[degrees\\]'}, {'measure': 'Motek Grail output (joint moments)', 'timeFrame': '40 minutes', 'description': 'Joint moments calculated using HBM Gait model \\[Newton\\*meter/kilogram\\]'}, {'measure': 'Motek Grail output (ground reaction forces)', 'timeFrame': '40 minutes', 'description': 'Ground reaction forces calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot \\[Newtons\\]'}, {'measure': 'Motek Grail output (centre of pressure)', 'timeFrame': '40 minutes', 'description': 'Center of pressure calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot \\[meters\\]'}, {'measure': 'Body composition', 'timeFrame': '10 minutes', 'description': 'Body composition using Tanita Body Composition Monitor (fat tissue percentage, muscle mass percentage, water percentage)'}, {'measure': 'Range of movement', 'timeFrame': '20 minutes', 'description': 'Range of movement in hip, knee and ankle joint, measured using SFTR system \\[degrees\\]'}, {'measure': 'Height', 'timeFrame': '2 minutes', 'description': 'Height measured in meters'}, {'measure': 'Weight', 'timeFrame': '2 minutes', 'description': 'Weight measured in kilograms'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motek grail', 'balance', 'gait perturbation'], 'conditions': ['Balance Disorders']}, 'descriptionModule': {'briefSummary': 'Investigators would like to examine, what are strategies for balance recovery in gait perturbations. Different perturbation types where used in the current study. The study involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that research including young healthy adults would help to elaborate fall prevention program for seniors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-35\n* female or male\n* good health condition\n\nExclusion Criteria:\n\n* lower limb injuries (last 6 months)\n* head injuries (last 6 months)\n* diseases of the vestibular system\n* serious eye defects\n* extreme sports athletes'}, 'identificationModule': {'nctId': 'NCT03813004', 'briefTitle': 'Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Józef Piłsudski University of Physical Education'}, 'officialTitle': 'Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults', 'orgStudyIdInfo': {'id': 'DS-311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Young healthy adults', 'interventionNames': ['Diagnostic Test: Reaction for gait perturbation']}], 'interventions': [{'name': 'Reaction for gait perturbation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants were subjected to four different perturbation types while walking on the treadmill:\n\n1. left treadmill belt deceleration for right leg toe off\n2. right treadmill belt deceleration for left leg toe off\n3. left treadmill belt acceleration for right leg heel strike\n4. right treadmill belt acceleration for left leg heel strike\n\nMotion analysis was conducted to analyze effect of the intervention on gait.', 'armGroupLabels': ['Young healthy adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-968', 'city': 'Warsaw', 'state': 'Mazowsze', 'country': 'Poland', 'facility': 'Józef Piłsudski University of Physical Education in Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Łysoń', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barbara Łysoń', 'investigatorAffiliation': 'Józef Piłsudski University of Physical Education'}}}}