Comprehensive Therapeutic Program For People With Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 75
SponsorCharles University, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed clinical diagnosis of MS

Age ≤ 75 years

Predominantly motor impairment

EDSS 2-8

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Outpatient physiotherapy

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSISExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The Nine Hole Peg test (NHPT)

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

Time frame
Baseline and 4 months
2

The Four Square Step Test (FSST)

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

Time frame
baseline and endpoint at 4 months
3

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)

Time frame
baseline and endpoint at 4 months
4

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

Time frame
baseline and endpoint at 4 months

Secondary outcomes

1

Multiple Sclerosis Impact Scale (MSIS-29)

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

Time frame
baseline and end-point at 4 months
2

Modified Fatigue Impact Scale (MFIS)

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

Time frame
baseline and end-point at 4 months
3

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.

Time frame
baseline and end-point at 4 months
4

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

Time frame
baseline and 4 months

Other outcomes

Sponsors and contacts

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Charles University, Czech Republic

Lead sponsor

Ministry of Health, Czech Republic

Collaborator

This trial is not recruiting at the moment. You can still explore other options: