NCT06956326招募中2 期
Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation
Lars Hvid3 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Expanded Disability Status Scale (EDSS)
研究概览
简要总结
The overall purpose of this project is to develop and test an infrastructure that can ensure early and specialized rehabilitation for individuals with multiple sclerosis (MS) on their path to recovery from a relapse. If this project proves successful, it can therefore help optimize clinical practice and provide a significant contribution to the treatment of relapsing-remitting sclerosis.
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
- Single (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
- •admitted to the Danish MS Hospitals for an inpatient rehabilitation stay
- •confirmed motor relapse (within the past 6 months) by a neurologist, with disability/ functional interference characterized by change in pyramidal, and/or cerebellar functional scores of 2 or higher
- •completed steroid or other acute relapse treatment, if prescribed
- •age over 18 years
排除标准
- •more than 6 months since onset of motor relapse
- •medical conditions or substantial cognitive impairments that hinder participation in the study (e.g. inability to perform or understand the intensive rehabilitation)
- •pregnancy
结局指标
主要结局
Expanded Disability Status Scale (EDSS)
时间窗: Change from Baseline to 52 weeks
The Expanded Disability Status Scale measures your current level of disability.
MS Functional Composite (MSFC) Score
时间窗: Change from Baseline to 52 weeks
A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).
次要结局
- Six spot step test (SSST)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Five times sit to stand chair rise test (5STS)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Five times sit to stand chair rise test muscle power (5STS_power)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Patient determined disease steps (PDDS)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- MS Walking Scale (MSWS)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Falls Efficacy Scale International (short FES-I)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Functional Assessment of MS (FAMS)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Manual Ability Measurement (MAM36)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Modified Fatigue Impact Scale (MFIS)(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
- Multiple Sclerosis Cognitive Scale (MSCS)(Changes from baseline to 2 weeks, 10 weeks, and 52 weeks)
- Treatment Satisfactory Questionnaire (TSQ)(Evaluated at 2 weeks, 10 weeks, and 52 weeks)
- MS Functional Composite (MSFC) Score(Changes from Baseline to 2 weeks and 10 weeks)
- Handgrip strength(Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks)
研究者
Lars Hvid
Senior Researcher, PhD
Danish Multiple Sclerosis Hospitals
研究点 (3)
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