Multiple Sclerosis, Stroke
Conditions
Keywords
Stroke, Multiple Sclerosis, Mollii neuromodulation suit, Rehabilitation, Balance
Brief summary
* 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.
Interventions
OTHERthe Mollii garment with active stimulation
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.
OTHERMollii neuromodulation garment, but the stimulation program is not activated (placebo)
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.
Sponsors
Somogy Megyei Kaposi Mór Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* suffered a first ischemic stroke, diagnosed by a neurologist based on CT or MR imaging * neurological examination revealed mobility and postural limitations * confirmed multiple sclerosis diagnosed by a neurologist based on MRI imaging
Exclusion criteria
* multiple strokes in medical history * systolic blood pressure less than 120 or higher than 160 mmHg * orthostatic hypotension * arotid artery stenosis * severe heart disease * hemophilia * traumatic brain injury * seizure disorder * untreated diabetes * abnormal electroencephalography * abnormal blood panel * use of sedatives * irregular medication use * severe aphasia (Western Aphasia Battery ≤ 25) * severe visual or hearing impairment * severe sensory dysfunction * severe orthopedic problems * other neurological conditions affecting motor function * alcoholism * drug use * smoking after diagnosis of stroke * unable to walk at least 10 m with or without assistance in 6 minutes * BBS score ≤ 32 * BI score ≤ 70 * current participation in individual or group exercise program outside of standard physical therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) | 4 weeks | Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is. |
| Barthel Index (BI) | 4 weeks | Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | 4 weeks | Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance. |
| Tinetti | 4 weeks | Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk. |
| Timed Up and Go (TUG) | 4 weeks | Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling. |
| Stroke Impact Scale (SIS) | 4 weeks | Physical and psychological functions after stroke scaling 0-100 points, higher score means better post-stroke functions. |
| 10 meter walk test (10mWT) | 4 weeks | Walking speed |
| Posturographic examination | 4 weeks | Postural instability |
| 3D motion analysis | 4 weeks | Movement dynamics, gait |
| 6 minute walk test (6MWT) | 4 weeks | Functional exercise capacity |
| Multiple Sclerosis Impact Scale (MSIS-29) | 4 weeks | Physical and psychological effects in MS, scaling 0-100 points, where higher scores mean greater disease impact. |
Countries
Hungary
Contacts
Primary ContactBarbara Kopácsi
Backup ContactJózsef Dr. habil. Tollár
Outcome results
None listed