Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis

NCT04973501 | Completed

• 1 other identifier: EK-VP/25/0/2014/2
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Rehabilitation; Musculoskeletal Complication

Keywords

Developmental kinesiology; Physiotherapy; Muscle imbalance; Musculoskeletal disorders

Outcome Measures

Primary Outcomes (7)

• 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

• Berg Balance Scale (BBS)

  14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)

  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

  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.

  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.

  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.

  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.

  six months

Secondary Outcomes (6)

• Questionnaires - The Fatigue scale for motor and cognitive functions (FSMC)

  six months

• Questionnaires -Multiple Sclerosis Impact Scale (MSIS-29)

  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

Study Arms (2)

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.

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.

Behavioral: Dynamic Neuromuscular Stabilization (DNS) Method

Interventions

Manual physiotherapeutic correction (MFK) Method BEHAVIORAL

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.

Manual physiotherapeutic correction (MFK) Method

Dynamic Neuromuscular Stabilization (DNS) Method BEHAVIORAL

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.

Dynamic Neuromuscular Stabilization (DNS) Method

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other neurological disease or conditions disabling movement (e.g. stroke, pregnancy, fracture)

Sponsors & Collaborators

• Charles University, Czech Republic: lead

MeSH Terms

Conditions

Multiple Sclerosis; Musculoskeletal Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kamila Řasová, Ph.D.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. Kamila Řasová, Ph.D.

Model Details: The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 22, 2021
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07