Multiple Sclerosis
Conditions
Brief summary
Leg spasticity is common problem encountered with a large proportion of patients suffering with multiple sclerosis (MS) with an increasing severity as the disease progresses. It mostly affects the antigravity muscles that significantly complicates transfer, increases fatigue and makes walking more difficult. Hence, leg spasticity often interferes with patients' mobility and significantly influences their quality of life. A great number of multidisciplinary rehabilitation studies has shown a significant effect of numerous specific functional changes in patients with secondary (SP) and primary progressive (PP) MS but there are no reviews related to spasticity. The positive therapeutic effect of modulating Transcranial Magnetic Stimulation ( TMS) methods on spasticity is shown in only two studies, in patients with relapse remitting clinical form in the remission phase of the disease. The effect of TMS on clinical measures of lower limb spasticity, functional inability and the quality of life in patients with SPMS and PPMS will be examined in this study. The objective to this study are to to explore whether rTMS boosted exercise therapy (ET) treatment can bring more improvement in lower limb spasticity than ET treatment alone in these patients.
Interventions
DEVICETranscranial magnetic stimulation
TMS 1Hz under the motor zone of cortex.
OTHERConventional exercise
Exercise will be administrated in a conventional way.
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Confirmed clinical form of SPMS and PPMS (established on the basis of the revised McDonald criteria) * EDDS score 2-6.5 * lower limb spasticity caused by MS * 18 years ≥age of the patient ≤ 65. years
Exclusion criteria
* clinical worsening of the disease over the past 30 days, * the presence of pregnancy, dementia, alcoholism, history of loss of consciousness, epilepsy, metal objects in the head, pacemakers and other electronic devices in the body at a distance of 20cm from the top of the patients head, serious associate diseases (malignancy, heart disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| muscle tone measured by Modified Ashworth Scale (MAS) | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88) | 3 weeks |
| Activities of daily living measured by Barthel Index | 3 weeks |
| Walking mobility measured by Timed 25 Foot Walk test | 3 weeks |
| Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54). | 3 weeks |
Countries
Serbia
Outcome results
None listed