* Objective assessment of clinical symptoms resulting from stroke, as well as changes in mobility and quality of life, and determination of changes resulting from therapies * Objective assessment of the quality of life, functionality, and clinical symptoms of patients with multiple sclerosis (MS) and determination of changes resulting from therapies * Comparison of measured data from the two main neurological patient groups (stroke, multiple sclerosis) and follow-up of changes in relation to themselves and each other. * Mapping the role of the placebo effect in neuromodulation devices by comparing subjective and objective outcomes. * Analyzing the expectations and experiences of patients receiving placebo treatment using quality of life questionnaires. * Analyzing the effects of the Mollii suit among subgroups of MS and stroke patients. * Assessing the safety, possible side effects, and tolerability of the Mollii suit. * Mapping changes in gait pattern due to the effects of therapy using 3D motion analysis. * Examining the maintenance effects of neuromodulation during a 1-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Patients in the Intervention group attend therapy three days a week for four weeks, with each treatment lasting 60 minutes. In this group patients are fitted with the Mollii garment according to the same protocol, but in their case, active stimulation of the prescribed neuromodulation program is initiated.
CG patients are fully equipped with the Mollii neuromodulation garment, but the stimulation program is not activated. The patient thus completes the therapy without the device's perceptible electrical stimulation, preserving the blinding effect of the placebo-controlled setup. The total treatment time, setup process, and therapeutic environment are the same as for the intervention group.
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, Hungary
RECRUITINGFunctional Independence Measure (FIM)
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
Time frame: 4 weeks
Barthel Index (BI)
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
Time frame: 4 weeks
Stroke Impact Scale (SIS)
Physical and psychological functions after stroke scaling 0-100 points, higher score means better post-stroke functions.
Time frame: 4 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
Physical and psychological effects in MS, scaling 0-100 points, where higher scores mean greater disease impact.
Time frame: 4 weeks
Berg Balance Scale (BBS)
Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance.
Time frame: 4 weeks
Tinetti
Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk.
Time frame: 4 weeks
Timed Up and Go (TUG)
Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling.
Time frame: 4 weeks
6 minute walk test (6MWT)
Functional exercise capacity
Time frame: 4 weeks
10 meter walk test (10mWT)
Walking speed
Time frame: 4 weeks
Posturographic examination
Postural instability
Time frame: 4 weeks
3D motion analysis
Movement dynamics, gait
Time frame: 4 weeks
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