Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT07248657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Therapeutic Program For People With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007266', 'term': 'Inhibition, Psychological'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}], 'ancestors': [{'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Nine Hole Peg test (NHPT)', 'timeFrame': 'Baseline and 4 months', 'description': 'measures speed (in seconds) of this fine hand movement task'}, {'measure': 'The Four Square Step Test (FSST)', 'timeFrame': 'baseline and endpoint at 4 months', 'description': 'Time (in seconds) to reach clockwise and counterclockwise stepping task'}, {'measure': 'The 2-Minute Walking Test (2MWT)', 'timeFrame': 'baseline and endpoint at 4 months', 'description': 'The distance one is able walk in two minutes, including noting stops needed and mobility aids (e.g., crutches, canes, or walkers)'}, {'measure': 'The Symbol Digit Modalities Test (SDMT)', 'timeFrame': 'baseline and endpoint at 4 months', 'description': 'A brief neuropsychological test assessing attention, visual scanning, processing speed, and working memory. Participants match symbols to numbers according to a reference key within a limited time - 90 seconds - the final score is result'}], 'secondaryOutcomes': [{'measure': 'Multiple Sclerosis Impact Scale (MSIS-29)', 'timeFrame': 'baseline and end-point at 4 months', 'description': "Questionnaires to measure the physical and the psychological impact of multiple sclerosis form the patient's perspective."}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'baseline and end-point at 4 months', 'description': 'Questoionnaire to assess impact of fatigue on namely tasks and life situations in PwMS.'}, {'measure': 'Activities-Specific Balance Confidence Scale (ABC scale)', 'timeFrame': 'baseline and end-point at 4 months', 'description': 'Participants: For each of the following activities, please indicate your level of confidence in doing the activity without losing balance. The confidence is assessed in percentage, and all results are finally averaged.'}, {'measure': 'International Classification of Functioning, Disability and Health (ICF) assessment', 'timeFrame': 'baseline and 4 months', 'description': "Brief core set for Multiple Sclerosis is used to assess the participant's situation with use of the ICF"}, {'measure': 'tremor assessment', 'timeFrame': 'baseline and 4 months', 'description': 'Assessment of tremor of upper limbs while holding one arm forward for 60 seconds. Measured with closed and opened eyes by accelerometer. he spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - lower value, lower tremor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'rehabilitation', 'physiotherapy', 'psychotherapy', 'psychological support', 'exercise', 'neurorehabilitation', 'facilitation and inhibition'], 'conditions': ['Multiple Sclerosis', 'Neurorehabilitation', 'Rehabilitation', 'Rehabilitation Exercise']}, 'descriptionModule': {'briefSummary': 'This study investigates the effectiveness of an intensive multidisciplinary rehabilitation program for people with multiple sclerosis (PwMS). The program integrates intensive outpatient physiotherapy, psychotherapeutic consultations, and nutritional counseling to enhance motor and cognitive functions, promote neuroplasticity, and improve overall well-being as well as physical performance in PwMS. Through clinical assessments and standardized questionnaires, the study aims to provide scientific evidence on the benefits of comprehensive, non-pharmacological therapy as a core element in MS treatment.', 'detailedDescription': 'Multiple sclerosis (MS) is a chronic neurological disease predominantly affecting young adults and often leads to significant limitations in both professional and social life. Current therapeutic approaches apart from pharmacotherapy, emphasize non-pharmacological interventions, rehabilitation, and holistic lifestyle modifications (Duan, 2023).\n\nThis study provides individuals with MS the opportunity to participate in an intensive 4-month single-arm therapeutic program that combines specialized outpatient physiotherapy, psychotherapy, and nutritional counseling. The physiotherapy component is based on a scientifically validated approach-Motor Program Activating Therapy-which directly targets motor control and central nervous system function (Řasová, 2015).The program was developed by two physiotherapists specializing in MS during their doctoral studies (Procházková, 2020; Prokopiusová, 2020), whose research focused on factors influencing disease progression and the efficacy of physiotherapeutic interventions. In this prospective study participants will undergo outpatient program aiming to enhance neuroplasticity, improve physical and psychological functions, physical performance and contribute to long-term health maintenance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Confirmed clinical diagnosis of MS\n* Age ≤ 75 years\n* Predominantly motor impairment\n* EDSS 2-8\n* Ability and motivation to attend outpatient physiotherapy regularly\n\nExclusion criteria:\n\n• Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder'}, 'identificationModule': {'nctId': 'NCT07248657', 'acronym': 'BIB_MS', 'briefTitle': 'Comprehensive Therapeutic Program For People With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Comprehensive Therapeutic Program For People With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'UK3LF/57 1290 12025-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS', 'description': 'This is a prospective single-arm study. Participants will undergo a four-month rehabilitation program consisting of physiotherapy sessions twice per week for the first two months (50 minutes each), once weekly during the third month, and once every two weeks in the fourth month. All participants will receive a combined outpatient intervention consisting of individually tailored physiotherapy and group psychotherapy.\n\nPhysiotherapy will focus on posture correction, movement control, and functional mobility using the Motor Program Activating Therapy method, complemented by Dynamic Muscular Stabilization, manual, and soft-tissue techniques. Additionally, participants will attend three 90-minute group psychotherapy sessions aimed at supporting mental well-being, stress management, and motivation during rehabilitation, including education on coping strategies, relaxation, and nutrition.', 'interventionNames': ['Procedure: Outpatient physiotherapy', 'Procedure: group psychotherapy']}], 'interventions': [{'name': 'Outpatient physiotherapy', 'type': 'PROCEDURE', 'description': "Physiotherapy sessions will be individually tailored according to each participant's goals. Soft tissue and joint techniques will be used as needed to prepare the body for optimal posture activation in sitting, standing, walking, and other movements. Therapists will use reflex, mobilization, and soft-tissue techniques. The Motor Program Activating Therapy method will be the primary approach, complemented by Dynamic Muscular Stabilization and movement self-awareness techniques.", 'armGroupLabels': ['COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS']}, {'name': 'group psychotherapy', 'type': 'PROCEDURE', 'description': 'In addition, all participants will attend three 90-minute group psychotherapy sessions led by a psychologist. These sessions will support mental well-being, stress management, and motivation throughout the physiotherapy process. Participants will learn practical coping strategies for emotions, pain, and psychological strain. Relaxation techniques will be demonstrated and practiced, and basic nutritional recommendations will be provided in written or online form.', 'armGroupLabels': ['COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Terezie Prokopiusova, Mgr., Ph.D.', 'role': 'CONTACT', 'email': 'protelovrovnovaze@gmail.com', 'phone': '+420 737 449 662'}, {'name': 'Marie Prochazkova, Mgr., Ph.D.', 'role': 'CONTACT', 'email': 'prochazkova777@gmail.com'}, {'name': 'Barbora Miznerova, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assossiation for Body in Balance', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Kamila Rasova, prof.', 'role': 'CONTACT', 'email': 'kamila.rasova@gmail.com', 'phone': '+420604511416'}, {'name': 'Barbora Miznerova, MD', 'role': 'CONTACT', 'email': 'barbora.miznerova@ftn.cz', 'phone': '+420776480210'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. PhDr. Kamila Rasova, Ph.D.', 'investigatorFullName': 'Kamila Řasová', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}