Evaluation of the Effect of the Physiotherapy on Mobility and Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 50
- Primary Endpoint
- Four Square Step Test (FSST)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Kamila Řasová
assoc. prof. Kamila Řasová, Ph.D.
Charles University, Czech Republic
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)
Outcomes
Primary Outcomes
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.
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)
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.
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
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.
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.
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.
Secondary Outcomes
- Questionnaires -Multiple Sclerosis Impact Scale (MSIS-29)(six months)
- Questionnaires - The Fatigue scale for motor and cognitive functions (FSMC)(six months)
- Questionnaires- Activities-specific Balance Confidence Scale (ABC)(six months)
- Questionnaires - Euroqol-5 dimensions-5 levels health questionnaire(six months)
- Questionnaires -Multiple Sclerosis Walking Scale-12 (MSWS-12)(six months)
- Questionnaires - Rivermead Mobility (RMI)(six months)