Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Deceleration index
研究概览
简要总结
The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability.
The following three research questions will be addressed:
- How prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure?
- What are associated symptoms of walking-related motor fatigability and how long does this manifest?
- What is the relationship between cognitive fatigability and walking-related performance fatigability?
participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 - 70 years
- •Confirmed diagnosis according to the McDonald criteria
- •Performed a 6MWT before, to ensure familiarization
- •Able to walk independently or with unilateral support for 6 minutes without rest
- •Signed the informed consent
排除标准
- •Exacerbation or relapse within last 3 months before study
- •Other neurological diagnosis, such as stroke and Parkinson
- •MS-like syndromes, such as neuromyelitis optica
- •Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)
结局指标
主要结局
Deceleration index
时间窗: day 1
Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%
次要结局
- Symptom Inventory Questionnaire(day 4)
- spasticity(day 4)
- Strength(day 4)
- Balance(day 4)
- VAS fatigue(day 4)
- gait parameter(day 4)
- Cognitive fatigability(between week 1 and week 2 (no specific day: at the day the patients request))
- heart rate(day 4)
研究者
Peter Feys
Principal Investigator
Hasselt University