Comprehensive Therapeutic Program For People With Multiple Sclerosis

NCT07248657 | Not Yet Recruiting

• 1 other identifier: UK3LF/57 1290 12025-2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Neurorehabilitation; Rehabilitation; Rehabilitation Exercise

Keywords

multiple sclerosis; rehabilitation; physiotherapy; psychotherapy; psychological support; exercise; neurorehabilitation; facilitation and inhibition

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Multiple Sclerosis Impact Scale (MSIS-29)

  baseline and end-point at 4 months

• Modified Fatigue Impact Scale (MFIS)

  baseline and end-point at 4 months

• Activities-Specific Balance Confidence Scale (ABC scale)

  baseline and end-point at 4 months

• International Classification of Functioning, Disability and Health (ICF) assessment

  baseline and 4 months

• tremor assessment

  baseline and 4 months

Study Arms (1)

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.

Procedure: Outpatient physiotherapy; Procedure: group psychotherapy

Interventions

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.

COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS

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.

COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator

Study Sites (1)

Assossiation for Body in Balance

Prague, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Inhibition, Psychological

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Kamila Rasova, prof.

CONTACT

+420604511416; kamila.rasova@gmail.com

Barbora Miznerova, MD

CONTACT

+420776480210; barbora.miznerova@ftn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. PhDr. Kamila Rasova, Ph.D.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)