Comprehensive Therapeutic Program For People With Multiple Sclerosis (BIB_MS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis; Rehabilitation; Neurorehabilitation; Rehabilitation Exercise
• Intervention / Treatment: Procedure: Outpatient physiotherapy; Procedure: group psychotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamila Rasova, prof.; Phone Number: +420604511416; Email: kamila.rasova@gmail.com
• Study Contact Backup: Name: Barbora Miznerova, MD; Phone Number: +420776480210; Email: barbora.miznerova@ftn.cz

Study Locations

• Czechia
  • Prague, Czechia
    • Assossiation for Body in Balance
    • Contact: Terezie Prokopiusova, Mgr., Ph.D.; Phone Number: +420 737 449 662; Email: protelovrovnovaze@gmail.com
    • Contact: Marie Prochazkova, Mgr., Ph.D.; Email: prochazkova777@gmail.com
    • Principal Investigator: Barbora Miznerova, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Confirmed clinical diagnosis of MS
• Age ≤ 75 years
• Predominantly motor impairment
• EDSS 2-8
• Ability and motivation to attend outpatient physiotherapy regularly

Exclusion criteria:

• Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS; 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.

Procedure: Outpatient physiotherapy; 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.; Procedure: group psychotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Ministry of Health, Czech Republic

Study record dates

Study Major Dates

• Study Start (Estimated): December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Estimated): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; multiple sclerosis; psychotherapy; physiotherapy; neurorehabilitation; psychological support; facilitation and inhibition
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Behavior; Multiple Sclerosis; Motor Activity; Inhibition, Psychological; Psychotherapy; Behavioral Disciplines and Activities; Socioenvironmental Therapy; Psychotherapy, Group
• Other Study ID Numbers: UK3LF/57 1290 12025-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No