Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis

Официальное название

Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis

Обзор

* 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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Functional Independence Measure (FIM) [Срок оценки: 4 weeks]
• Barthel Index (BI) [Срок оценки: 4 weeks]

Вторичные конечные точки (9)

• Stroke Impact Scale (SIS) [Срок оценки: 4 weeks]
• Multiple Sclerosis Impact Scale (MSIS-29) [Срок оценки: 4 weeks]
• Berg Balance Scale (BBS) [Срок оценки: 4 weeks]
• Tinetti [Срок оценки: 4 weeks]
• Timed Up and Go (TUG) [Срок оценки: 4 weeks]
• 6 minute walk test (6MWT) [Срок оценки: 4 weeks]
• 10 meter walk test (10mWT) [Срок оценки: 4 weeks]
• Posturographic examination [Срок оценки: 4 weeks]
• 3D motion analysis [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Венгрия · 1 центр

• Somogy County Kaposi Mór Teaching Hospital — Kaposvár

Идентификаторы

NCT: NCT07333222 · IG/4390-0/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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