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NCT Number: NCT07248657

Comprehensive Therapeutic Program For People With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inhibition, Psychological Motor Activity Nervous System Diseases Neurorehabilitation Rehabilitation Rehabilitation Exercise

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The Nine Hole Peg test (NHPT)

    Time frame: Baseline and 4 months

    measures speed (in seconds) of this fine hand movement task

  2. The Four Square Step Test (FSST)

    Time frame: baseline and endpoint at 4 months

    Time (in seconds) to reach clockwise and counterclockwise stepping task

  3. The 2-Minute Walking Test (2MWT)

    Time frame: baseline and endpoint at 4 months

    The distance one is able walk in two minutes, including noting stops needed and mobility aids (e.g., crutches, canes, or walkers)

  4. The Symbol Digit Modalities Test (SDMT)

    Time frame: baseline and endpoint at 4 months

    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

Secondary outcomes

  1. Multiple Sclerosis Impact Scale (MSIS-29)

    Time frame: baseline and end-point at 4 months

    Questionnaires to measure the physical and the psychological impact of multiple sclerosis form the patient's perspective.

  2. Modified Fatigue Impact Scale (MFIS)

    Time frame: baseline and end-point at 4 months

    Questoionnaire to assess impact of fatigue on namely tasks and life situations in PwMS.

  3. Activities-Specific Balance Confidence Scale (ABC scale)

    Time frame: baseline and end-point at 4 months

    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.

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

    Time frame: baseline and 4 months

    Brief core set for Multiple Sclerosis is used to assess the participant's situation with use of the ICF

  5. tremor assessment

    Time frame: baseline and 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbora Miznerova, MD

CONTACT

[email protected]

+420776480210

Kamila Rasova, prof.

CONTACT

[email protected]

+420604511416

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Ministry of Health, Czech Republic

Registry information

Acronym: BIB_MS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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