Functional and Quality of Life Effects of the Mollii Neuromodulatory S
Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- the Mollii garment with active stimulation
Placebo
- Mollii neuromodulation garment, but the stimulation program is not activated (placebo)
What it measured
Main measures
Functional Independence Measure (FIM)
4 weeks
Barthel Index (BI)
4 weeks
Other measures (9)
Stroke Impact Scale (SIS)
4 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
4 weeks
Quality of life (reported by participants)Berg Balance Scale (BBS)
4 weeks
Walking and mobilityTinetti
4 weeks
Walking and mobilityTimed Up and Go (TUG)
4 weeks
Walking and mobility6 minute walk test (6MWT)
4 weeks
Walking and mobilityPhysical function10 meter walk test (10mWT)
4 weeks
Walking and mobilityPosturographic examination
4 weeks
3D motion analysis
4 weeks
Walking and mobility
Who could take part
MS (type not specified) · 18 to 99
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
* 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.
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History
Started
Jan 2026
Main results due
Dec 2026
Finished
Aug 2028