Multiple SclerosisNCT04973501
Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
A study testing Manual physiotherapeutic correction (MFK) Method and Dynamic Neuromuscular Stabilization (DNS) Method in people with Multiple Sclerosis and Rehabilitation, run by Charles University, Czech Republic.
Trial summary
The randomized controlled trial is aimed to study the efficacy of treatment approaches based on developmental kinesiology models and its impact on balance, gait and mobility in people with mild to severe multiple sclerosis (pwMS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Rehabilitation, Musculoskeletal Complication
- What is being tested?
- Manual physiotherapeutic correction (MFK) Method and Dynamic Neuromuscular Stabilization (DNS) Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- exact diagnosis of MS stated by neurologist
- Expanded Disability Status Scale (EDSS) ≥ 2 and ≤ 6,5
- no previous physiotherapy in six months
- no clinical relapses and changes in pharmacotherapy in the previous month or during the rehabilitation trial
- ability to undergo ambulatory physiotherapy
Who cannot join
- other neurological disease or conditions disabling movement (e.g. stroke, pregnancy, fracture)
About this study
Official title: Evaluation of the Effect of the Physiotherapy on Mobility and Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
The randomized controlled trial is aimed to study the efficacy of treatment approaches based on developmental kinesiology models and its impact on balance, gait and mobility in people with mild to severe multiple sclerosis (pwMS). The main goal is to compare two out-patient physiotherapeutic methods, that will be attended 1-hour twice a week for one month and once a week for next two months (16 therapies in total). The efficacy will be assessed by a blinded independent clinical examiner using clinical examination and questionnaire survey one month before the therapy programme, immediately before and after the therapy and two months after termination of the therapy.
Read the detailed description
The participants were randomly divided into two groups for three-month outpatient physiotherapeutic programme.
One group obtained treatment by MFK Method (Manual physiotherapeutic correction) and the second by DNS (Dynamic Neuromuscular Stabilization ). Both treatment methods were developed in the Czech Republic. All participants attended 1-hour MFK Method or DNS twice a week for one month and once a week for next two months (16 therapies in total).
The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart.
- Being tested
- Manual physiotherapeutic correction (MFK) Method, Dynamic Neuromuscular Stabilization (DNS) Method
- Keywords
- Developmental kinesiology, Physiotherapy, Muscle imbalance, Musculoskeletal disorders
- Medical subject headings
- Multiple Sclerosis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual physiotherapeutic correction (MFK) MethodBehavioural
Patients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague.
Dynamic Neuromuscular Stabilization (DNS) MethodBehavioural
Patients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total).Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Manual physiotherapeutic correction (MFK) Method | Experimental | The MFK was chosen for our clinical experience- it was developed in Czech Republic.The MFK Method consists of five established steps: anamnesis, assessment, diagnoses, treatment and checkup. In the course of all those steps, the computer MFK System software is used. This software allows us to display and visualize the patient´s functional muscle imbalance at the day of the assesment based on the assessment of muscle strength by manual muscle tests. Hereafter the physiotherapist performs muscle test and records results in the software. Then, the software visually describes the patient´s imbalance at the day of the assessment. Based on these diagnostic maps and the software suggestions the therapist chooses the body areas where the therapeutic techniques may be applied. Receives: Behavioral: Manual physiotherapeutic correction (MFK) Method |
| Dynamic Neuromuscular Stabilization (DNS) Method | Experimental | Dynamic Neuromuscular Stabilization (DNS) is a neurophysiological rehabilitative approach encompassing a set of functional tests assessing the quality of postural stabilization patterns and a treatment approach based on developmental kinesiology models. DNS diagnosis is based on comparison of the individual's postural stabilization pattern to the developmental stabilization pattern of healthy infants. The assessor uses DNS evaluation sheet to screen client's posture in 11 developmental positions if the patient can perform them all. If not, only the tests that the patient can perform sufficiently and safely serve for functional assessment. The strategy of DNS manual treatment is to utilize only those functional exercises in developmental positions that are the most suitable for the specific client. The goal is to improve spinal and joint stability by focusing on the global stabilization system consequently improving quality of movement and mobility. Receives: Behavioral: Dynamic Neuromuscular Stabilization (DNS) Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
The TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: six months
Berg Balance Scale (BBS)
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Measured: six months
Dynamic Gait Index (DGI)
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions.
It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent.
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment.
The best possible score on the DGI is a 24
Measured: six months
Five times Sit to Stand test (5STS)
The test assesses time when people stand and sit repeatedly five times. The lower the time to complete the test the better the outcome of the test.
Measured: six months
2-Minute Walk Test (2MWT)
The 2MWT is a simple measure of the distance a person can walk in two minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used. If Assistive devices are used , they should be kept consistent and documented from test to test.
Measured: six months
Symbol Digit Modalities Test (SDMT)
The SDMT involves a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Because examinees can give either written or spoken responses, the test is well suited for use with individuals who have motor disabilities or speech disorders.
Measured: six months
Four Square Step Test (FSST)
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground.
At the start of the test, the subject stands in Square 1 facing Square 2. The aim is to step as fast as possible into each square with both feet in the following sequence: Square 2, 3, 4, 1, 4, 3, 2, 1 (clockwise to counterclockwise) Test procedure may be demonstrated, one practice trial is allowed prior to administering the test.
Two trials are then performed, and the better time (in seconds) is taken as the score.
Timing starts when the first foot contacts the floor in Square 2 and finishes when the last foot comes back to touch the floor in Square 1.
Measured: six months
Secondary outcomes (6)
Questionnaires - The Fatigue scale for motor and cognitive functions (FSMC)
FSMC - is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
Measured: six months
Questionnaires -Multiple Sclerosis Impact Scale (MSIS-29)
A 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on a day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5" extremely". Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates the greater impact of the disease on daily function (worse health).
Measured: six months
Questionnaires - Euroqol-5 dimensions-5 levels health questionnaire
Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has three severity levels that are described by statements appropriate to that dimension. A higher number means a worse quality of life.
Measured: six months
Questionnaires -Multiple Sclerosis Walking Scale-12 (MSWS-12)
The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100.
Measured: six months
Questionnaires - Rivermead Mobility (RMI)
The Rivermead Mobility Index is a measuring instrument for functional loss related to body mobility. It measures the patient's ability to move her or his own body.
14-self-reported items
1 direct observation item Items progress in difficulty Items are coded as either 0 or 1, depending on whether the patient can complete the task according to specific instructions Items receive a score of 0 for a "No" response and 1 for a "Yes" response Total scores are determined by summing the points for all items A maximum of 15 points is possible; higher scores indicate better mobility performance A score of "0" indicates an inability to perform any of the activities on the measure
Measured: six months
Questionnaires- Activities-specific Balance Confidence Scale (ABC)
The patient is asked to rate their confidence in their balance, while performing 16 activities, on a percentage scale of 0 to 100, where 0 is a certainty of falling or becoming unstable and 100 is complete confidence in the patient's own ability to stay balanced.
The final score is the average of the 16 individual scores for each activity.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study startMay 2016
- Primary completionMay 2018
- Study completionDec 2020
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.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamila Řasová, Charles University, Czech Republic
- Investigators
- Kamila Řasová, Ph.D., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973501
- Sponsor's protocol ID
- EK-VP/25/0/2014/2
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Physiotherapy on Mobility and Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04973501
- Acronym / sponsor ID
- EK-VP/25/0/2014/2
- Keywords
- Developmental kinesiology, Physiotherapy, Muscle imbalance, Musculoskeletal disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 Jul 2021 (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.
The randomized controlled trial is aimed to study the efficacy of treatment approaches based on developmental kinesiology models and its impact on balance, gait and mobility in people with mild to severe multiple sclerosis (pwMS). The main goal is to compare two out-patient physiotherapeutic methods, that will be attended 1-hour twice a week for one month and once a week for next two months (16 therapies in total). The efficacy will be assessed by a blinded independent clinical examiner using clinical examination and questionnaire survey one month before the therapy programme, immediately before and after the therapy and two months after termination of the therapy.
Detailed description
The participants were randomly divided into two groups for three-month outpatient physiotherapeutic programme.
One group obtained treatment by MFK Method (Manual physiotherapeutic correction) and the second by DNS (Dynamic Neuromuscular Stabilization ). Both treatment methods were developed in the Czech Republic. All participants attended 1-hour MFK Method or DNS twice a week for one month and once a week for next two months (16 therapies in total).
The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions.
| Arm | Type | Receives |
|---|---|---|
| Manual physiotherapeutic correction (MFK) Method | Experimental | Behavioral: Manual physiotherapeutic correction (MFK) MethodThe MFK was chosen for our clinical experience- it was developed in Czech Republic.The MFK Method consists of five established steps: anamnesis, assessment, diagnoses, treatment and checkup. In the course of all those steps, the computer MFK System software is used. This software allows us to display and visualize the patient´s functional muscle imbalance at the day of the assesment based on the assessment of muscle strength by manual muscle tests. Hereafter the physiotherapist performs muscle test and records results in the software. Then, the software visually describes the patient´s imbalance at the day of the assessment. Based on these diagnostic maps and the software suggestions the therapist chooses the body areas where the therapeutic techniques may be applied. |
| Dynamic Neuromuscular Stabilization (DNS) Method | Experimental | Behavioral: Dynamic Neuromuscular Stabilization (DNS) MethodDynamic Neuromuscular Stabilization (DNS) is a neurophysiological rehabilitative approach encompassing a set of functional tests assessing the quality of postural stabilization patterns and a treatment approach based on developmental kinesiology models. DNS diagnosis is based on comparison of the individual's postural stabilization pattern to the developmental stabilization pattern of healthy infants. The assessor uses DNS evaluation sheet to screen client's posture in 11 developmental positions if the patient can perform them all. If not, only the tests that the patient can perform sufficiently and safely serve for functional assessment. The strategy of DNS manual treatment is to utilize only those functional exercises in developmental positions that are the most suitable for the specific client. The goal is to improve spinal and joint stability by focusing on the global stabilization system consequently improving quality of movement and mobility. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- exact diagnosis of MS stated by neurologist
- Expanded Disability Status Scale (EDSS) ≥ 2 and ≤ 6,5
- no previous physiotherapy in six months
- no clinical relapses and changes in pharmacotherapy in the previous month or during the rehabilitation trial
- ability to undergo ambulatory physiotherapy
Key exclusion criteria (1 listed)
- other neurological disease or conditions disabling movement (e.g. stroke, pregnancy, fracture)
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 |
|---|---|---|
| Manual physiotherapeutic correction (MFK) MethodPatients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague. | Behavioural | Manual physiotherapeutic correction (MFK) Method |
| Dynamic Neuromuscular Stabilization (DNS) MethodPatients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total).Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital. | Behavioural | Dynamic Neuromuscular Stabilization (DNS) Method |
Primary outcome
Timed Up and Go (TUG)
Time frame: six months
The TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Berg Balance Scale (BBS)
Time frame: six months
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Dynamic Gait Index (DGI)
Time frame: six months
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24
Five times Sit to Stand test (5STS)
Time frame: six months
The test assesses time when people stand and sit repeatedly five times. The lower the time to complete the test the better the outcome of the test.
2-Minute Walk Test (2MWT)
Time frame: six months
The 2MWT is a simple measure of the distance a person can walk in two minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used. If Assistive devices are used , they should be kept consistent and documented from test to test.
Symbol Digit Modalities Test (SDMT)
Time frame: six months
The SDMT involves a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Because examinees can give either written or spoken responses, the test is well suited for use with individuals who have motor disabilities or speech disorders.
Four Square Step Test (FSST)
Time frame: six months
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. At the start of the test, the subject stands in Square 1 facing Square 2. The aim is to step as fast as possible into each square with both feet in the following sequence: Square 2, 3, 4, 1, 4, 3, 2, 1 (clockwise to counterclockwise) Test procedure may be demonstrated, one practice trial is allowed prior to administering the test. Two trials are then performed, and the better time (in seconds) is taken as the score. Timing starts when the first foot contacts the floor in Square 2 and finishes when the last foot comes back to touch the floor in Square 1.
6 secondary outcomes
Questionnaires - The Fatigue scale for motor and cognitive functions (FSMC)
Time frame: six months
Questionnaires -Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: six months
Questionnaires - Euroqol-5 dimensions-5 levels health questionnaire
Time frame: six months
Questionnaires -Multiple Sclerosis Walking Scale-12 (MSWS-12)
Time frame: six months
Questionnaires - Rivermead Mobility (RMI)
Time frame: six months
Questionnaires- Activities-specific Balance Confidence Scale (ABC)
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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. This study is not recruiting at the moment.
Kamila Řasová, Ph.D. principal investigator
Charles University, Czech Republic
Questions about this trial
What is this clinical trial studying?
A study testing Manual physiotherapeutic correction (MFK) Method and Dynamic Neuromuscular Stabilization (DNS) Method in people with Multiple Sclerosis and Rehabilitation, run by Charles University, Czech Republic.
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: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: six months). The study lists 7 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 22 Jul 2021.