Multiple SclerosisBIB_MSNCT07248657
Comprehensive Therapeutic Program For People With Multiple Sclerosis
A study testing Outpatient physiotherapy and group psychotherapy in people with Multiple Sclerosis and Neurorehabilitation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Multiple Sclerosis, Neurorehabilitation, Rehabilitation
- What is being tested?
- Outpatient physiotherapy and group psychotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed clinical diagnosis of MS
- Age ≤ 75 years
- Predominantly motor impairment
- EDSS 2-8
- Ability and motivation to attend outpatient physiotherapy regularly
Who cannot join
- Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Assossiation for Body in Balance
Prague
Terezie Prokopiusova, Mgr., Ph.D., +420 737 449 662, protelovrovnovaze@gmail.com
Marie Prochazkova, Mgr., Ph.D., prochazkova777@gmail.com
About this study
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.
Read the 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.
- Being tested
- Outpatient physiotherapy, group psychotherapy
- Keywords
- multiple sclerosis, rehabilitation, physiotherapy, psychotherapy, psychological support, exercise, neurorehabilitation, facilitation and inhibition
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient physiotherapyProcedure or 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 psychotherapyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Outpatient physiotherapy; Procedure: group psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nine Hole Peg test (NHPT)
measures speed (in seconds) of this fine hand movement task
Measured: Baseline and 4 months
The Four Square Step Test (FSST)
Time (in seconds) to reach clockwise and counterclockwise stepping task
Measured: 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)
Measured: 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
Measured: baseline and endpoint at 4 months
Secondary outcomes (5)
Multiple Sclerosis Impact Scale (MSIS-29)
Questionnaires to measure the physical and the psychological impact of multiple sclerosis form the patient's perspective.
Measured: baseline and end-point at 4 months
Modified Fatigue Impact Scale (MFIS)
Questoionnaire to assess impact of fatigue on namely tasks and life situations in PwMS.
Measured: baseline and end-point at 4 months
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.
Measured: baseline and end-point at 4 months
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
Measured: baseline and 4 months
tremor assessment
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.
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start5 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Responsible party
- Principal investigator, Kamila Řasová, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248657
- Sponsor's protocol ID
- UK3LF/57 1290 12025-2
- Acronym
- BIB_MS
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Therapeutic Program For People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07248657
- Acronym / sponsor ID
- BIB_MS / UK3LF/57 1290 12025-2
- Keywords
- multiple sclerosis, rehabilitation, physiotherapy, psychotherapy, psychological support, exercise, neurorehabilitation, facilitation and inhibition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- 5 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS | Experimental | Procedure: Outpatient physiotherapy, Procedure: group psychotherapyThis 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. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed clinical diagnosis of MS
- Age ≤ 75 years
- Predominantly motor impairment
- EDSS 2-8
- Ability and motivation to attend outpatient physiotherapy regularly
Key exclusion criteria (1 listed)
- Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient physiotherapyPhysiotherapy 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 or surgery | COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS |
| group psychotherapyIn 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. | Procedure or surgery | COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS |
Primary outcome
The Nine Hole Peg test (NHPT)
Time frame: Baseline and 4 months
measures speed (in seconds) of this fine hand movement task
The Four Square Step Test (FSST)
Time frame: baseline and endpoint at 4 months
Time (in seconds) to reach clockwise and counterclockwise stepping task
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)
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
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RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
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RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
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RecruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient physiotherapy and group psychotherapy in people with Multiple Sclerosis and Neurorehabilitation, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamila Rasova, prof. (+420604511416, kamila.rasova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nine Hole Peg test (NHPT) (time frame: Baseline and 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.