Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01074827
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2010-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-06', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking ability', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Strength', 'timeFrame': '8 weeks'}, {'measure': 'Work economy O2', 'timeFrame': '8 weeks'}, {'measure': 'Balance', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Walking ability', 'Strength', 'Balance', 'Treadmill walking'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '26110230', 'type': 'RESULT', 'citation': 'Braendvik SM, Koret T, Helbostad JL, Loras H, Brathen G, Hovdal HO, Aamot IL. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial. Physiother Res Int. 2016 Dec;21(4):228-236. doi: 10.1002/pri.1636. Epub 2015 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive\n* Expanded Disability Status Scale (EDSS)score of ≤ 6\n* Reduced walking ability (subjectively experienced)\n\nExclusion Criteria:\n\n* persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.\n* spasticity requiring stretching og treatment with baclofen.\n* Other, not MS-related, conditions affecting walking ability.'}, 'identificationModule': {'nctId': 'NCT01074827', 'briefTitle': 'Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '09/225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill group', 'description': 'Specific gait training on treadmill', 'interventionNames': ['Other: Strength training and treadmill training']}, {'type': 'EXPERIMENTAL', 'label': 'Strength training group', 'description': 'Eight weeks of intensive strength training', 'interventionNames': ['Other: Strength training and treadmill training']}], 'interventions': [{'name': 'Strength training and treadmill training', 'type': 'OTHER', 'description': 'Eight weeks of intensive strength training or treadmill training', 'armGroupLabels': ['Strength training group', 'Treadmill group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Siri M, Brændvik', 'role': 'STUDY_CHAIR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'Helse Midt-Norge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}