Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
Recruiting · NCT07333222 · Interventional (participants receive a specific treatment) · Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
* 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.
Who can take part
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
Where it is running
1 location listed.
- Somogy County Kaposi Mór Teaching Hospital - Kaposvár, Somogy County, Hungary