Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-01-29 @ 7:23 PM
Study NCT ID:
NCT02947906
Status:
UNKNOWN
Last Update Posted:
2016-10-28
First Post:
2016-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plantar Pressure Distribution in Patient With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pedobarography for assessment of foot pressure while standing and walking', 'timeFrame': 'Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes', 'description': 'Participant stands and walks on system name is pedobarography which records foot pressure. Foot pressure means, gravitational force reflecting from ground at every foot step phase. Newton/cm2 is the unit of measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gait', 'Loading', 'Multiple Sclerosis', 'Plantar Pressure'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be participants of the study.Participants with multiple sclerosis will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic pedobarography.', 'detailedDescription': 'Fifty patients who were referred to receive physiotherapy at the neurology department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Hacettepe University, Ankara with multiple sclerosis and twenty voluntary healthy age matched participants will be the subjects of this study.\n\nAssessment tools described as following: Modified Ashworth scale will use to evaluate of severity of plantar flexor spasticity. Static and dynamic loading parameters will be evaluate with pedobarography.Maximum loading pressure -N/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with multiple sclerosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Want to participate Individuals with multiple sclerosis who can walk alone for 30 meters Healthy participants who diagnosed no disorders or orthopedic problems.\n\nExclusion Criteria:\n\n* Want to participate Individuals with multiple sclerosis who can walk alone for 50 meters Healthy participants who diagnosed no disorders or orthopedic problems.'}, 'identificationModule': {'nctId': 'NCT02947906', 'briefTitle': 'Plantar Pressure Distribution in Patient With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigating the Plantar Pressure Distribution in Patient With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'G0 16/344'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Participants with multiple sclerosis who able to walk at least 30 meters independently.', 'interventionNames': ['Other: No intervention']}, {'label': 'Control Group', 'description': 'Healthy participants', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Control Group', 'Study group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, PT', 'investigatorFullName': 'hhotaman', 'investigatorAffiliation': 'Hacettepe University'}}}}