Clinical trial NCT04973501: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Rehabilitation
Musculoskeletal Complication
Keywords: Developmental kinesiology
Physiotherapy
Muscle imbalance
Musculoskeletal disorders
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: six months
measure: Berg Balance Scale (BBS)
timeFrame: six months
measure: Dynamic Gait Index (DGI)
timeFrame: six months
measure: Five times Sit to Stand test (5STS)
timeFrame: six months
measure: 2-Minute Walk Test (2MWT)
timeFrame: six months
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: six months
measure: Four Square Step Test (FSST)
timeFrame: six months
Secondary outcomes:
measure: Questionnaires - The Fatigue scale for motor and cognitive functions (FSMC)
timeFrame: six months
measure: Questionnaires -Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: six months
measure: Questionnaires - Euroqol-5 dimensions-5 levels health questionnaire
timeFrame: six months
measure: Questionnaires -Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: six months
measure: Questionnaires - Rivermead Mobility (RMI)
timeFrame: six months
measure: Questionnaires- Activities-specific Balance Confidence Scale (ABC)
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Third Faculty of Medicine Charles University
name: Kamila Řasová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: