Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Evaluation of the Effect of the Physiotherapy on Mobility and Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973501
• Other study ID #: EK-VP/25/0/2014/2
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2020

Study information

• Verified date: July 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Musculoskeletal Complication
• Rehabilitation
• Sclerosis

Intervention

Behavioral:
• Manual physiotherapeutic correction (MFK) Method
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) Method
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six months
Primary	Berg Balance Scale (BBS)	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)	six months
Primary	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	six months
Primary	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.	six months
Primary	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.	six months
Primary	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.	six months
Primary	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.	six months
Secondary	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).	six months
Secondary	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).	six months
Secondary	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.	six months
Secondary	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.	six months
Secondary	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	six months
Secondary	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.	six months