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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
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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.
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).
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS | Experimental | 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. Physiotherapy 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient physiotherapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Nine Hole Peg test (NHPT) | measures speed (in seconds) of this fine hand movement task | Baseline and 4 months |
| The Four Square Step Test (FSST) | Time (in seconds) to reach clockwise and counterclockwise stepping task | baseline and endpoint at 4 months |
| The 2-Minute Walking Test (2MWT) | The distance one is able walk in two minutes, including noting stops needed and mobility aids (e.g., crutches, canes, or walkers) | baseline and endpoint at 4 months |
| The Symbol Digit Modalities Test (SDMT) | 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 | baseline and endpoint at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Impact Scale (MSIS-29) | Questionnaires to measure the physical and the psychological impact of multiple sclerosis form the patient's perspective. | baseline and end-point at 4 months |
| Modified Fatigue Impact Scale (MFIS) |
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Inclusion criteria:
Exclusion criteria:
• Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kamila Rasova, prof. | Contact | +420604511416 | kamila.rasova@gmail.com | |
| Barbora Miznerova, MD | Contact | +420776480210 | barbora.miznerova@ftn.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assossiation for Body in Balance | Prague | Czechia |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| D007266 | Inhibition, Psychological |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| group psychotherapy | Procedure | 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. |
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Questoionnaire to assess impact of fatigue on namely tasks and life situations in PwMS.
| baseline and end-point at 4 months |
| Activities-Specific Balance Confidence Scale (ABC scale) | 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. | baseline and end-point at 4 months |
| International Classification of Functioning, Disability and Health (ICF) assessment | Brief core set for Multiple Sclerosis is used to assess the participant's situation with use of the ICF | baseline and 4 months |
| tremor assessment | 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. | baseline and 4 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |