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Comprehensive Therapeutic Program For People With Multiple Sclerosis

Comprehensive Therapeutic Program For People With Multiple Sclerosis

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07248657
Acronym
BIB_MS
Enrollment
26
Registered
2025-11-25
Start date
2025-12-05
Completion date
2026-12-31
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Neurorehabilitation, Rehabilitation, Rehabilitation Exercise

Keywords

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

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.

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.

Interventions

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.

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.

Sponsors

Ministry of Health, Czech Republic
CollaboratorOTHER_GOV
Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Nine Hole Peg test (NHPT)Baseline and 4 monthsmeasures speed (in seconds) of this fine hand movement task
The Four Square Step Test (FSST)baseline and endpoint at 4 monthsTime (in seconds) to reach clockwise and counterclockwise stepping task
The 2-Minute Walking Test (2MWT)baseline and endpoint at 4 monthsThe distance one is able walk in two minutes, including noting stops needed and mobility aids (e.g., crutches, canes, or walkers)
The Symbol Digit Modalities Test (SDMT)baseline and endpoint at 4 monthsA 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

MeasureTime frameDescription
Multiple Sclerosis Impact Scale (MSIS-29)baseline and end-point at 4 monthsQuestionnaires to measure the physical and the psychological impact of multiple sclerosis form the patient's perspective.
tremor assessmentbaseline and 4 monthsAssessment 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.
Modified Fatigue Impact Scale (MFIS)baseline and end-point at 4 monthsQuestoionnaire to assess impact of fatigue on namely tasks and life situations in PwMS.
Activities-Specific Balance Confidence Scale (ABC scale)baseline and end-point at 4 monthsParticipants: 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.
International Classification of Functioning, Disability and Health (ICF) assessmentbaseline and 4 monthsBrief core set for Multiple Sclerosis is used to assess the participant's situation with use of the ICF

Countries

Czechia

Contacts

Primary ContactKamila Rasova, prof.
kamila.rasova@gmail.com+420604511416
Backup ContactBarbora Miznerova, MD
barbora.miznerova@ftn.cz+420776480210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026