Back to resultsFunctional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Rehabilitation, Musculoskeletal Complication
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual physiotherapeutic correction (MFK) Method
Dynamic Neuromuscular Stabilization (DNS) Method
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Developmental kinesiology, Physiotherapy, Muscle imbalance, Musculoskeletal disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- other neurological disease or conditions disabling movement (e.g. stroke, pregnancy, fracture)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manual physiotherapeutic correction (MFK) Method
Dynamic Neuromuscular Stabilization (DNS) Method
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Berg Balance Scale (BBS)
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
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
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.
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.
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.
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.
Secondary Outcome Measures
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).
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).
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.
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.
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
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.
Full Information
NCT ID
NCT04973501
First Posted
July 1, 2021
Last Updated
July 21, 2021
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04973501
Brief Title
Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
Official Title
Evaluation of the Effect of the Physiotherapy on Mobility and Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Rehabilitation, Musculoskeletal Complication
Keywords
Developmental kinesiology, Physiotherapy, Muscle imbalance, Musculoskeletal disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual physiotherapeutic correction (MFK) Method
Arm Type
Experimental
Arm Description
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.
Arm Title
Dynamic Neuromuscular Stabilization (DNS) Method
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Manual physiotherapeutic correction (MFK) Method
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic Neuromuscular Stabilization (DNS) Method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
six months
Title
Berg Balance Scale (BBS)
Description
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Time Frame
six months
Title
Dynamic Gait Index (DGI)
Description
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
Time Frame
six months
Title
Five times Sit to Stand test (5STS)
Description
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.
Time Frame
six months
Title
2-Minute Walk Test (2MWT)
Description
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.
Time Frame
six months
Title
Symbol Digit Modalities Test (SDMT)
Description
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.
Time Frame
six months
Title
Four Square Step Test (FSST)
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Questionnaires - The Fatigue scale for motor and cognitive functions (FSMC)
Description
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).
Time Frame
six months
Title
Questionnaires -Multiple Sclerosis Impact Scale (MSIS-29)
Description
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).
Time Frame
six months
Title
Questionnaires - Euroqol-5 dimensions-5 levels health questionnaire
Description
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.
Time Frame
six months
Title
Questionnaires -Multiple Sclerosis Walking Scale-12 (MSWS-12)
Description
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.
Time Frame
six months
Title
Questionnaires - Rivermead Mobility (RMI)
Description
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
Time Frame
six months
Title
Questionnaires- Activities-specific Balance Confidence Scale (ABC)
Description
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.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
other neurological disease or conditions disabling movement (e.g. stroke, pregnancy, fracture)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamila Řasová, Ph.D.
Organizational Affiliation
Third Faculty of Medicine Charles University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
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