Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT06056960
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'Baseline, Post, FollowUp_6month', 'description': 'Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4.'}], 'secondaryOutcomes': [{'measure': 'Differences in oxygenated hemoglobin (Delta oxyHb)', 'timeFrame': 'Baseline, Post, FollowUp_6month', 'description': 'The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.'}, {'measure': 'Six Minute walking test (6MWT)', 'timeFrame': 'Baseline, Post, FollowUp_6month', 'description': "Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test."}, {'measure': 'Number of steps/day', 'timeFrame': 'Baseline, Post, FollowUp_6month', 'description': 'Assessed by activity trackers, a non-invasive method of monitoring human rest/activity cycles. Subjects will be monitored for 1 week wearing an actigraph.'}, {'measure': 'Endurance walking capacity', 'timeFrame': 'Baseline, Post, FollowUp_6month', 'description': 'Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early phase', 'non-disabled'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.\n\nThere is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.\n\nTo the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 17 years\n* Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)\n\nExclusion Criteria:\n\n* Major depression\n* Mini-Mental State Examination \\< 27\n* Other cardiovascular or orthopedic diseases that interfere with physical exercise\n* Progressive course of the disease'}, 'identificationModule': {'nctId': 'NCT06056960', 'briefTitle': 'Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B', 'orgStudyIdInfo': {'id': '03_17/02/2021 Part B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity', 'description': 'The experimental group will perform a combination of endurance and balance training tailored to the subject.', 'interventionNames': ['Other: Tailored Physical Activity']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Activity', 'description': 'The control group will perform their usual daily activities.'}], 'interventions': [{'name': 'Tailored Physical Activity', 'type': 'OTHER', 'description': 'The intervention will comprise 16 sessions (2 sessions/week). 30 minutes of walking training wearing a heart rate (HR) monitor to keep exercise intensity below 70% of maximal HR.\n\nRight after, 30 minutes of balance exercises will be performed. An experienced physical therapist will tailor exercises. Subjects will be taught how to perform the exercises by themselves. A booklet will be provided to provide guidelines. A physical therapist will call subjects, every training day to check for any problem.', 'armGroupLabels': ['Physical Activity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cagliari', 'country': 'Italy', 'facility': 'Ospedale Binaghi ASL Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20148', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Fondazione Don Carlo Gnocchi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Marco Rovaris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Fondazione Don Carlo Gnocchi'}, {'name': 'Raffaella Chieffo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}, {'name': 'Eleonora Cocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Binaghi ASL Cagliari, Sardegna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, {'name': 'Azienda Sanitaria Locale di Cagliari', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}