Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
NCT ID: NCT07333222
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2026-01-12
2028-08-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mollii Group
Receaving treatment with the stimulation program.
the 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.
Control Group
Receaving treatment without the stimulation program.
Mollii 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.
Interventions
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the 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.
Mollii 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.
Eligibility Criteria
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Inclusion Criteria
* neurological examination revealed mobility and postural limitations
* confirmed multiple sclerosis diagnosed by a neurologist based on MRI imaging
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Somogy Megyei Kaposi Mór Teaching Hospital
OTHER
Responsible Party
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Tollár József
Head of Department
Principal Investigators
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József Dr. habil Tollár
Role: PRINCIPAL_INVESTIGATOR
Somogy County Kaposi Mór Teaching Hospital
Locations
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Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IG/4390-0/2025
Identifier Type: -
Identifier Source: org_study_id
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