Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- NHPT+SSST score
研究概览
简要总结
This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning.
Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?
Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).
Participants in the intervention group will:
- Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home).
- Receive their usual care in addition to wearing the suit.
- Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.
Participants in the control group will:
- Receive their usual care.
- Undergo clincial tests at the same time points as the other group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must have ataxia or spasticity alongside impairments in upper or lower extremity physical function. MAS score ≥ 1 will be used as an inclusion criterion to determine the presence of spasticity. SARA score ≥ 4 will be used as an inclusion criterion to determine the presence of ataxia. Note: one of the two criteria (MAS score or SARA score) must be fulfilled for a pwMS to be eligible.
- •The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately
- •Diagnosis of multiple sclerosis.
排除标准
- •Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment )
- •Change in disease modifying treatment within the last 3 months
- •Use of Botuline Toxine A within the last 3months
- •Recent relapse within the last 3 months
- •Acute musculoskeletal problems that hinder the test performance,
- •Pregnancy
- •Sizes bigger than 3XL (triple eXtra Large)
- •Skin eruptions and/or skin areas in the stimulation zone that are swollen, infected or inflamed.
研究组 & 干预措施
stimulation suit group
This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care.
干预措施: electro-stimulation suit (Device)
stimulation suit group
This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care.
干预措施: Usual Care (Other)
usual care
This group will be a comparator and have no added intervention expect for their usual care.
干预措施: Usual Care (Other)
结局指标
主要结局
NHPT+SSST score
时间窗: After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.
The primary outcome will be a combined measure of upper and lower extremity motor function, consisting of the Nine Hole Peg Test and the Six Spot step test (labelled NHPT+SSST score). Values are expressed in seconds. A higher score, indicates a worse outcome.
次要结局
- 6 Minute walk test(The assessment will take place after weeks 1 and 6 of stimulation.)
- 5 times sit to stand test (5STS)(The assessment will take place after weeks 1 and 6 of stimulation.)
- adapted Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM 1.4)(The adapted TSQM 1.4 assessment will take place after weeks 1 and 6 of stimulation. Only for the intervention group)
- SymptoMScreen(SymptoMScreen assessment will take place weekly from the start of the intervention until end of the study.)
- Modified Fatigue Impact Scales (MFIS)(The assessment will take place after weeks 1 and 6 of stimulation.)
- Six spot step test (SSST)(SSST assessment will take place after weeks 1 and 6 of stimulation.)
- Nine Hole Peg Test (NHPT)(NHPT assessment will take place after weeks 1 and 6 of stimulation.)
- Modified Ashworth Scale (MAS)(MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.)
- Scale for the Assessment and Rating of Ataxia (SARA)(SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.)
- Numeric Rating Scale (NRS)(NRS assessments will take place after weeks 1 and 6 of stimulation.)
- The patient-Determined Disease Steps (PDDS)(PDDS assessment will take place after weeks 1 and 6 of stimulation.)
- The 12-item Multiple Sclerosis Walking Scale (MSWS12)(MSWS-12 assessment will take place after weeks 1 and 6 of stimulation.)
- The 36-item Manual Ability Measurement (MAM36)(MAM36 assessment will take place after weeks 1 and 6 of stimulation.)
- The EuroQol Questionnaire (EQ-D5)(EQ-5D assessment will take place after weeks 1 and 6 of stimulation.)
研究者
Daphne Kos
Professor
Universitair Ziekenhuis Brussel