Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-04 @ 1:06 AM
Study NCT ID:
NCT02209467
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2014-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance and Falls in 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2014-08-04', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Berg Balance Scale at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in 10 repetitions Sit to stand test at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline in Trunk Impairment scale at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline in the Trunk Impairment Scale at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline in the 10 repetition Si to stand test at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline in the Berg Balance scale at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline on the Timed Up and Go test at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline on the Timed Up and Go test at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline on the10 meter walking test at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline on the 10 meter walking test at 15 weks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline on the 2 minutes walking test at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline on the 2 minutes walking test at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline in postural sway at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline in postural sway at 15 weeks', 'timeFrame': 'baseline, 15 weeks', 'description': 'postural sway in standing on the floor is assessed'}, {'measure': 'Change from baseline on the Falls-Efficacy scale at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline on the Falls Efficacy scale at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'Change from baseline on the MS Walking Scale-12 at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'Change from baseline on the MS Walking scale-12 at 15 weeks', 'timeFrame': 'baseline, 15 weeks'}, {'measure': 'The number of falls and accidental falls', 'timeFrame': 'from baseline to 15 weeks', 'description': 'the number of falls and accidental falls are noted by the participant in a study-specific falls diary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['walking', 'postural balance', 'falls'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '25004466', 'type': 'BACKGROUND', 'citation': 'Nilsagard YE, von Koch LK, Nilsson M, Forsberg AS. Balance exercise program reduced falls in people with multiple sclerosis: a single-group, pretest-posttest trial. Arch Phys Med Rehabil. 2014 Dec;95(12):2428-34. doi: 10.1016/j.apmr.2014.06.016. Epub 2014 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that for people with moderate to severe multiple sclerosis postural balance and walking improve and the risk of accidental falls are reduced after participating in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain a further 7 weeks post training.\n\nMultiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural balance are often affected early in the course of the disease. The risk of falls is large. Many persons with MS have decreased trunk stability compared to healthy persons . In an earlier study including people with mild to moderate MS we found that a period of core stability exercises reduced the risk of falls. In this study the training concept will be applied for persons with more severe walking limitations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed multiple sclerosis\n* Expanded Disability Scale Score of 5-6.5\n* walking speed of less than 0.8 m/s as tested on a 10 meter walking test\n\nExclusion Criteria:\n\n* Ongoing relapse\n* Cognitive or language difficulties that prohibit participating in the intervention or performing the outcome measures\n* Change in specific MS medication during the last 30 days'}, 'identificationModule': {'nctId': 'NCT02209467', 'briefTitle': 'Balance and Falls in Multiple Sclerosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro County Council'}, 'officialTitle': 'Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins', 'orgStudyIdInfo': {'id': 'Researchweb 153691'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group balance training late start', 'description': 'Participants randomized to late start act as No intervention group during the study period.'}, {'type': 'EXPERIMENTAL', 'label': 'Group balance training early start', 'description': 'Group balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.', 'interventionNames': ['Other: Group balance training']}], 'interventions': [{'name': 'Group balance training', 'type': 'OTHER', 'description': 'Group balance training 60 minutes 2 times per week plus 3-5 home exercises 2 times/week. Exercises focus om core stability in sitting, standing and lying.', 'armGroupLabels': ['Group balance training early start']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eskilstuna', 'country': 'Sweden', 'facility': 'Neurorehab Mälarsjukhuset', 'geoPoint': {'lat': 59.36661, 'lon': 16.5077}}, {'city': 'Gävle', 'country': 'Sweden', 'facility': 'Physiotherapy department Gävle hospital', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'city': 'Karlskoga', 'country': 'Sweden', 'facility': 'Rehab unit Karlskoga hospital', 'geoPoint': {'lat': 59.32667, 'lon': 14.52386}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Primary Health Care', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Nyköping', 'country': 'Sweden', 'facility': 'Nyköping hospital', 'geoPoint': {'lat': 58.753, 'lon': 17.00788}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': 'Physiotherapy department University hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Västerås', 'country': 'Sweden', 'facility': 'Rehab unit Västerås hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Anna Carling, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Health Care Sciences, Örebro County Council'}, {'name': 'Anette Forsberg, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Family Medicine Research Centre, Örebro County Council'}, {'name': 'Ylva Nilsagård, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Health Care Sciences, Örebro County Council'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro County Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, lecturer', 'investigatorFullName': 'Anette Forsberg, PhD', 'investigatorAffiliation': 'Örebro County Council'}}}}