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Not yet recruiting NCT07248657

Comprehensive Therapeutic Program For People With Multiple Sclerosis

No phase Interventional Multiple Sclerosis Neurorehabilitation Rehabilitation Rehabilitation Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Outpatient physiotherapy, group psychotherapy.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Neurorehabilitation, Rehabilitation, Rehabilitation Exercise. Basic parameters: up to 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • The Nine Hole Peg test (NHPT) [Time frame: Baseline and 4 months]
  • The Four Square Step Test (FSST) [Time frame: baseline and endpoint at 4 months]
  • The 2-Minute Walking Test (2MWT) [Time frame: baseline and endpoint at 4 months]
  • The Symbol Digit Modalities Test (SDMT) [Time frame: baseline and endpoint at 4 months]
Secondary outcome measures (5)
  • Multiple Sclerosis Impact Scale (MSIS-29) [Time frame: baseline and end-point at 4 months]
  • Modified Fatigue Impact Scale (MFIS) [Time frame: baseline and end-point at 4 months]
  • Activities-Specific Balance Confidence Scale (ABC scale) [Time frame: baseline and end-point at 4 months]
  • International Classification of Functioning, Disability and Health (ICF) assessment [Time frame: baseline and 4 months]
  • tremor assessment [Time frame: baseline and 4 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Assossiation for Body in Balance — Prague

Identifiers

NCT: NCT07248657 · UK3LF/57 1290 12025-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗