Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:43 PM
Study NCT ID:
NCT04145934
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in Walking Aid Satisfaction', 'timeFrame': 'At baseline, 8 weeks, and 8 months', 'description': 'Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)'}, {'measure': 'Change from Baseline in Physical Activity', 'timeFrame': 'At baseline, 8 weeks, and 8 months', 'description': 'International Physical Activity Questionnaire (IPAQ)'}, {'measure': 'Change from Baseline in Walking Ability', 'timeFrame': 'At baseline, 8 weeks, and 8 months', 'description': 'Multiple Sclerosis Walking Scale-12 (MSWS-12). Min/max score: 12/60, higher indicates worse outcome'}, {'measure': 'Change from Baseline in Quality of Life', 'timeFrame': 'At baseline, 8 weeks, and 8 months', 'description': 'Multiple Sclerosis Impact Scale-29 (MSIS-29). Min/max score: 29/145, higher indicates worse outcome'}], 'primaryOutcomes': [{'measure': 'Change from Baseline in Self-Reported Falls at 8 months', 'timeFrame': 'daily for 8 months', 'description': 'Paper Fall Calendars'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Functional Gait Assessment / Dynamic Gait Index', 'timeFrame': 'At baseline, 8 weeks, and 8 months', 'description': 'Functional Gait Assessment / Dynamic Gait Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fall prevention', 'walking aid', 'physical therapy'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial of the Assistive Device Selection, Training, and Education Program (ADSTEP). ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.\n\nParticipants will be randomized to receive ADSTEP or a waitlist control intervention; those in the control condition will receive National MS Society brochures on fall prevention and walking aid selection, and a letter will be sent informing their care provider that the subject reports falling. All subjects will complete an assessment visit at baseline, and follow-up assessments at about 8 weeks and about 6 months after that. Subjects will complete paper questionnaires of patient reported outcomes (PROs), a modified Functional Gait Assessment / Dynamic Gait Index, and will track fall sustained over their participation in the study using monthly paper fall calendars. At the end of study participation, all subjects in the control group will be offered the opportunity to receive ADSTEP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A definite diagnosis of MS of any type;\n2. 18 years of age or older;\n3. Self-reported history of at least one fall in the previous year;\n4. Ability to walk at least 25 feet with or without an assistive device;\n5. Intermittent or constant unilateral or bilateral assistance required to walk;\n6. No MS exacerbations for the past 30 days;\n7. Willingness to complete a written daily record of falls for about 8 months.\n\nExclusion Criteria:\n\n1. Currently receiving physical therapy, or having any plans to receive physical therapy in the upcoming 8 months (duration of study participation);\n2. Serious psychiatric or medical conditions that would preclude reliable participation in the study (e.g. dementia, deafness, blindness);\n3. Inability to follow directions in English.'}, 'identificationModule': {'nctId': 'NCT04145934', 'acronym': 'ADSTEP', 'briefTitle': 'A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS', 'orgStudyIdInfo': {'id': '20191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training', 'description': 'The subjects receive the ADSTEP intervention', 'interventionNames': ['Behavioral: ADSTEP']}, {'type': 'NO_INTERVENTION', 'label': 'waitlist', 'description': 'These subjects receive two brochures on fall prevention and walking aid selection, and a letter is sent to their care provider informing them that the subject has reported falling. Subjects in this group will be offered the ADSTEP intervention once their study participation is complete.'}], 'interventions': [{'name': 'ADSTEP', 'type': 'BEHAVIORAL', 'description': 'ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.', 'armGroupLabels': ['training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Michelle Cameron, PT, MD, MCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health & Science University / VA Portland Health Care System'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will become available shortly after completion of data collection (anticipated for December 2021). Data will be available indefinitely thereafter.', 'ipdSharing': 'YES', 'description': 'All data obtained will be placed in a data repository maintained at the VA Portland Health Care System. Data in the repository will be accessible to other researchers at the discretion of the repository director, upon execution of a data use agreement.', 'accessCriteria': 'Execution of a data use agreement with VA Portland Health Care System'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Portland VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurologist', 'investigatorFullName': 'Michelle Cameron', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}