Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-02-26 @ 12:03 AM
Study NCT ID:
NCT01871818
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2013-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011331', 'term': 'Private Practice'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Minute Walk Test', 'timeFrame': '6 Minutes', 'description': '6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)'}], 'secondaryOutcomes': [{'measure': 'Functional tests', 'timeFrame': '20 Minutes', 'description': 'Functional tests: 10 meters Walk Test, Timed up and go test, Time to ascend and descend stairs, 6 Minute Walk Test\n\nTime frame:10 meters walk test = 2 min ; time up and going test= 4 min ; Time to ascend and descend stairs = 4 min ; et 6min walk = 6min'}, {'measure': 'Aerobic capacity', 'timeFrame': '1h', 'description': 'Aerobic capacity (V02 max)'}, {'measure': 'Strength and fatigue of the knee flexors and extensors', 'timeFrame': '45 min', 'description': 'Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation'}, {'measure': 'Clinical assessment', 'timeFrame': '45 min', 'description': 'Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain.'}, {'measure': 'Balance (Berg Balance scale) and postural control assessment', 'timeFrame': '15 min'}, {'measure': 'Quality of Life assessment', 'timeFrame': '55 min', 'description': 'Quality of Life assessed by self-reported questionnaire (SEP -59; EQ-5D), mood (HAD), MSIS-29, auto-questionnaire estimating the fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Rehabilitation', 'Chronic evolutive disease', 'Physiotherapy', 'Resistance training', 'Endurance training'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39818009', 'type': 'DERIVED', 'citation': 'Bonnyaud C, Hameau S, Zory R, Sznajder M, Heinzlef O, Aymard C, Chenet A, Medee B, Jacota M, Gallien P, Bensmail D; Rehabmuscle Team. Intensive interdisciplinary specialized rehabilitation or regular physiotherapy for multiple sclerosis? A randomised controlled trial with economic evaluation. Ann Phys Rehabil Med. 2025 Mar;68(2):101898. doi: 10.1016/j.rehab.2024.101898. Epub 2025 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.', 'detailedDescription': 'This study will include 240 patients with a diagnosis of Multiple Sclerosis and with an Expanded Disability Status Scale ≤ 5. Patients will be divided into 2 groups, according to a randomization design. At recruitment (J0), after rehabilitation (M1) and at follow up (M3 and M6) each patient will be tested for the primary and secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 year or over\n* Able to walk independently without use of assistance 200 meters Expanded Disability Status Scale ≤5\n* No relapse within the last three months\n* No current or recent (six months) participation in intensive rehabilitation\n* No recent modification (six months) of medications for MS\n* Patients who received and signed information and informed consent\n\nExclusion Criteria:\n\n* Cognitive impairments which could interfere with the ability to fully engage the rehabilitation program.\n* Recent involvement (three months) in another interventional research study\n* A complicating medical condition or orthopedic diagnosis that limits rehabilitation\n* Cardiac or respiratory disease that interfere with endurance training\n* Patient with safety measure\n* Pregnant women, breastfeeding\n* No affiliation to a social security'}, 'identificationModule': {'nctId': 'NCT01871818', 'acronym': 'REHABMUSCLE', 'briefTitle': 'A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'P110116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined program', 'description': 'Combined program with physiotherapy, endurance training and resistance training.\n\n120 patients will receive this combined program', 'interventionNames': ['Behavioral: Combined program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy', 'description': 'Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation', 'interventionNames': ['Behavioral: Physiotherapy in private practice']}], 'interventions': [{'name': 'Combined program', 'type': 'BEHAVIORAL', 'description': 'Combined program with physiotherapy, endurance training and resistance training', 'armGroupLabels': ['Combined program']}, {'name': 'Physiotherapy in private practice', 'type': 'BEHAVIORAL', 'description': 'Physiotherapy in private practice', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Hauts DE Seine', 'country': 'France', 'facility': 'Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Djamel Bensmail, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}