Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 8:00 AM
Study NCT ID:
NCT00424359
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2007-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambulation Study in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-12', 'studyFirstSubmitDate': '2007-01-17', 'studyFirstSubmitQcDate': '2007-01-18', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-19', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mulitple Sclerosis', 'Ambulation'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a study comparing clinical tests of walking and balance. The goal of this study is to discover which of those tests are best at predicting walking problems due to MS.', 'detailedDescription': 'This study includes:\n\nThree study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips.\n\nSubjects must meet the following criteria:\n\nDiagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment for the last three months; no scheduled hospitalization in the next six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with Multiple Sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer\n* Subject must have clinically definite MS according to McDonald criteria\n* Subject must have EDSS between 0-6.5\n* Subject must be aged 18-70\n* Subjects must be given informed consent\n* Subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study\n\nExclusion Criteria:\n\n* No MS relapse within the last 30 days\n* Subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. Hospitalization during the study may result in removal from the study\n* Medical conditions other than MS that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators\n* History or suspicion of non-compliance in the judgement of the investigators'}, 'identificationModule': {'nctId': 'NCT00424359', 'briefTitle': 'Ambulation Study in Multiple Sclerosis', 'nctIdAliases': ['NCT01355250'], 'organization': {'class': 'INDIV', 'fullName': 'Brown, Theodore R., M.D., MPH'}, 'officialTitle': 'A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'WIRB 20050607'}, 'secondaryIdInfos': [{'id': 'Pfizer Inc'}, {'id': 'Independent Grants 235-14-22'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Theodore R Brown, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MS Center at Evergreen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown, Theodore R., M.D., MPH', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'Theodore R. Brown, MD Mph', 'oldOrganization': 'MS Center at Evergreen'}}}}