Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-04 @ 6:39 AM
Study NCT ID:
NCT03230903
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Telerehabilitation 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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiorespiratory fitness', 'timeFrame': 'Baseline up to 6 months', 'description': 'Cardiorespiratory fitness will be measured by oxygen consumption'}], 'secondaryOutcomes': [{'measure': 'MS Self-efficacy scale', 'timeFrame': 'Baseline up to 6 months', 'description': 'MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS.'}, {'measure': 'Exercise adherence', 'timeFrame': 'Baseline up to 6 months', 'description': 'Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'Baseline up to 6 months', 'description': 'The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week.'}, {'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Baseline up to 6 months', 'description': 'BBS is a clinical 14-item scale designed to measure balance'}, {'measure': '2-Minute Walk Test (2MWT)', 'timeFrame': 'Baseline up to 6 months', 'description': 'Total distance walked in meters will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Telerehabilitation', 'Physical rehabilitation'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated Telemanagement) System as an adjunct to the current standard of medical care for patients with MS (PwMS). The individual patient with MS will be the unit of analysis. For each participant, the investigators will assess the effect of Home Automated Telemanagement (HAT) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.', 'detailedDescription': 'People with multiple sclerosis may develop severe disability over the time. Physical therapy including regular exercise helps patients with severe disability to maintain muscle strength, reduce disease symptoms and improve quality of life. However physical therapy programs at clinical settings require constant travel which may limit access of patients with mobility disability to these services on continuous basis.Technology can allow patients with mobility disability exercise at home under supervision of their rehabilitation team. Currently it is unclear how effective this approach is. The study aims to demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, less symptoms and better quality of life. If so, other patients with significant mobility disability will be able to take advantage of this technology. This approach can be extended to people with different diseases causing mobility impairment and it can be used not only for physical but also for cognitive and occupational rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>21\n* Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria\n* EDSS range 5.0-8.0\n* Mini-Mental State Examination (MMSE) \\> 22 or presence of a caregiver to assist in daily exercise regimen\n\nExclusion Criteria:\n\n* Coronary artery disease\n* Congestive Heart Failure\n* Uncontrolled hypertension\n* Epilepsy\n* Pacemaker or implanted defibrillator\n* Unstable fractures or other musculoskeletal diagnoses'}, 'identificationModule': {'nctId': 'NCT03230903', 'briefTitle': 'Physical Telerehabilitation in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment', 'orgStudyIdInfo': {'id': 'AAAQ7693'}, 'secondaryIdInfos': [{'id': 'MS150167', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home Telerehabilitation', 'description': 'The physical telerehabilitation group will receive an exercise plan, exercise equipment, a computer, and access to a daily individualized exercise plan. Participants in this group will follow the exercise plan that is sent to their computer via the telerehabilitation software. Participants will have interactions with a physical therapist and an exercise physiologist throughout training intervention.', 'interventionNames': ['Other: Home telerehabilitation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Usual Care', 'description': 'The usual care group will receive an individualized exercise program at baseline however participants will not receive the home telerehabilitation system or exercise equipment. Participants assigned to the usual care group will also not have access to the study physical therapist or exercise physiologist during the intervention.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Home telerehabilitation', 'type': 'OTHER', 'description': 'Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.', 'armGroupLabels': ['Home Telerehabilitation']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joel Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Simon Baruch Professor of Physical Medicine & Rehabilitation', 'investigatorFullName': 'Joel Stein, MD', 'investigatorAffiliation': 'Columbia University'}}}}