NCT07333222招募中不适用
Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
Somogy Megyei Kaposi Mór Teaching Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Functional Independence Measure (FIM)
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Mollii Group
Experimental
Receaving treatment with the stimulation program.
干预措施: the Mollii garment with active stimulation (Other)
Control Group
Placebo Comparator
Receaving treatment without the stimulation program.
干预措施: Mollii neuromodulation garment, but the stimulation program is not activated (placebo) (Other)
结局指标
主要结局
Functional Independence Measure (FIM)
时间窗: 4 weeks
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
Barthel Index (BI)
时间窗: 4 weeks
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
次要结局
- Stroke Impact Scale (SIS)(4 weeks)
- Multiple Sclerosis Impact Scale (MSIS-29)(4 weeks)
- Berg Balance Scale (BBS)(4 weeks)
- Tinetti(4 weeks)
- Timed Up and Go (TUG)(4 weeks)
- 6 minute walk test (6MWT)(4 weeks)
- 10 meter walk test (10mWT)(4 weeks)
- Posturographic examination(4 weeks)
- 3D motion analysis(4 weeks)
研究者
Tollár József
Head of Department
Somogy Megyei Kaposi Mór Teaching Hospital
研究点 (2)
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