Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- the Coordination test
研究概览
简要总结
This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing walking-related performance fatigability. In the second part of the study a pilot intervention will be executed to see if the investigators can improve the clinical status of the MS patients with walking-related performance 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 and 70 years.
- •MS diagnosis according to McDonald Criteria.
- •Capable of walking 6 minutes (independent or with unilateral support) without stopping.
排除标准
- •Exacerbation or relapse within last 3 months before study
- •Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
结局指标
主要结局
the Coordination test
时间窗: Day 1
Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.
TST (Triple Stimulation Technique)
时间窗: day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
TMS (Transcranial Magnetic Stimulation)
时间窗: Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
Motor function test (lower limb muscle strength)
时间窗: week 11
This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
Nine Hole Peg Test (NHPT)
时间窗: week 11
This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
Activity tracker
时间窗: Up to 5 days
A sensor will be placed around the foot and worn by the participant for 5 days and nights to evaluate physical activity and quality of sleep.
the Digit Span
时间窗: Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
the Stroop test
时间窗: week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
时间窗: week 11
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Glycocheck
时间窗: Baseline
A small camera will be placed under the tongue of the participant and blood vessels will be filmed to determine the quality of the blood vessels and immunity.
the Voluntary Drive test
时间窗: Day 1
The participant is seated in a Biodex. While performing a leg extension the Quadriceps muscle is stimulated to check the guidance of electrical signals to the muscles.
the Fatigability Index Legs
时间窗: Day 1
Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
Analysis of a Muscle Biopsy
时间窗: Day 3
A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
25 Foot Walk (T25FW) test
时间窗: week 11
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function.
Six minute walking test
时间窗: once during the observational study
Participant have to walk as far as they can for 6 minutes. Total distance walked and fatigability by comparing first and last minute distance will be calculated.
the Paced Auditory Serial Addition Test (PASAT)
时间窗: Week 11
This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3
Fatigability Index Hand
时间窗: week 11
Grip strength will be evaluated through a Jamar dynamometer.
次要结局
- Fatigue Scale of Motor and Cognitive Functions (FSMC)(week 11)
- Social Role Participation Questionnaire (SRPQ)(week 11)
- pre-interventionMSWS-12 score(week 11)
- Modified Fatigue Impact Scale (MFIS)(week 11)
- post-interventionMSWS-12 score(week 11)
- Multiple Sclerosis Impact Scale (MSIS-29)(week 11)
- Short Form Health survey (SF-36)(week 11)
- Fatigue severity scale (FSS)(week 11)
- The Sleep Condition Indicator (SCI)(week 11)
- Hospital Anxiety and Depression Scale (HADS)(Week 11)
研究者
Peter Feys
Principal Investigator
Hasselt University