Underlying Causes and Related Factors, and Rehabilitation Approaches
Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hasselt、比利时、3500
- Hasselt University
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Liège、比利时、4000
- Centre Hospitalier Universitaire de Liège
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 70 years.
- MS diagnosis according to McDonald Criteria.
- Capable of walking 6 minutes (independent or with unilateral support) without stopping.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Persons with MS, dance group
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Training intervention + Dance intervention
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有源比较器:Persons with MS, art group
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Training intervention + Dance intervention
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
符号数字模态测试(SDMT)(认知疲劳)
大体时间:第 11 周
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这是一项认知能力测试,通过注意力、速度和视觉扫描得到证实。
最后 30 秒的正确答案与前 30 秒的正确答案
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第 11 周
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九孔钉测试 (NHPT)
大体时间:第 11 周
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这是一项评估参与者手动技能的运动测试。
该测试记录参与者需要将 9 个别针放入钉板上并再次移除它们的时间。
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第 11 周
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the Coordination test
大体时间:Day 1
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Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.
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Day 1
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TST (Triple Stimulation Technique)
大体时间:day 3
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Technique in which nerves are stimulated to check guidance in the central nervous system
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day 3
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TMS (Transcranial Magnetic Stimulation)
大体时间:Day 3
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Technique in which nerves are stimulated to check guidance in the central nervous system
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Day 3
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the Voluntary Drive test
大体时间:Day 1
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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.
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Day 1
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the Fatigability Index Legs
大体时间:Day 1
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Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
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Day 1
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Analysis of a Muscle Biopsy
大体时间:Day 3
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A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
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Day 3
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the Digit Span
大体时间:Baseline
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Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
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Baseline
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the Digit Span
大体时间:Week 11
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Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
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Week 11
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the Stroop test
大体时间:Baseline
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Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
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Baseline
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the Stroop test
大体时间:week 11
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Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
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week 11
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the Paced Auditory Serial Addition Test (PASAT)
大体时间:Baseline
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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
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Baseline
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the Paced Auditory Serial Addition Test (PASAT)
大体时间:Week 11
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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
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Week 11
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the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
大体时间:Baseline
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his is a cognitive performance test, substantiated with focus, speed, and visual scanning.
Correct answers last 30 seconds vs first 30 seconds
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Baseline
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Motor function test (lower limb muscle strength)
大体时间:Baseline
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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.
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Baseline
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Motor function test (lower limb muscle strength)
大体时间:week 11
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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.
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week 11
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25 Foot Walk (T25FW) test
大体时间:Baseline
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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.
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Baseline
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25 Foot Walk (T25FW) test
大体时间:week 11
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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.
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week 11
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Nine Hole Peg Test (NHPT)
大体时间:Baseline
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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.
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Baseline
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Fatigability Index Hand
大体时间:Baseline
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Grip strength will be evaluated through a Jamar dynamometer.
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Baseline
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Fatigability Index Hand
大体时间:week 11
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Grip strength will be evaluated through a Jamar dynamometer.
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week 11
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Activity tracker
大体时间:Up to 5 days
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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.
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Up to 5 days
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Glycocheck
大体时间:Baseline
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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.
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Baseline
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Six minute walking test
大体时间:once during the observational study
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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.
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once during the observational study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Fatigue severity scale (FSS)
大体时间:baseline
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A self-report scale of nine items about fatigue, its severity and how it affects certain activities.
Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree.
This means the minimum score possible is nine and the highest is 63.
The higher the score, the more severe the fatigue is and the more it affects the person's activities.
It is simple to understand and takes an average of eight minutes to answer
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baseline
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Fatigue severity scale (FSS)
大体时间:week 11
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A self-report scale of nine items about fatigue, its severity and how it affects certain activities.
Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree.
This means the minimum score possible is nine and the highest is 63.
The higher the score, the more severe the fatigue is and the more it affects the person's activities.
It is simple to understand and takes an average of eight minutes to answer
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week 11
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Modified Fatigue Impact Scale (MFIS)
大体时间:baseline
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This is a short questionnaire to evaluate to impact of general fatigue.
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial.
The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
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baseline
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Modified Fatigue Impact Scale (MFIS)
大体时间:week 11
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This is a short questionnaire to evaluate to impact of general fatigue.
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial.The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
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week 11
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Fatigue Scale of Motor and Cognitive Functions (FSMC)
大体时间:baseline
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This is a short questionnaire to cognitive and motor fatigue in people with MS.
The FSMC is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
Two subscales (mental and physical fatigue) can be made.
Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
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baseline
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Fatigue Scale of Motor and Cognitive Functions (FSMC)
大体时间:week 11
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This is a short questionnaire to cognitive and motor fatigue in people with MS.
The FSMC is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
Two subscales (mental and physical fatigue) can be made.
Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
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week 11
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Hospital Anxiety and Depression Scale (HADS)
大体时间:baseline
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This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression..
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baseline
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Hospital Anxiety and Depression Scale (HADS)
大体时间:Week 11
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This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
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Week 11
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The Sleep Condition Indicator (SCI)
大体时间:baseline
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This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders.
The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
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baseline
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The Sleep Condition Indicator (SCI)
大体时间:week 11
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This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders.
The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
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week 11
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Social Role Participation Questionnaire (SRPQ)
大体时间:baseline
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This is a short questionnaire to evaluate social participation.
scale 1 (not important) - 5(very important)
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baseline
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Social Role Participation Questionnaire (SRPQ)
大体时间:week 11
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This is a short questionnaire to evaluate social participation.
scale 1 (not important) - 5 (very important)
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week 11
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pre-interventionMSWS-12 score
大体时间:baseline
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short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
baseline
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post-interventionMSWS-12 score
大体时间:baseline
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short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
baseline
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pre-interventionMSWS-12 score
大体时间:week 11
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short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
week 11
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post-interventionMSWS-12 score
大体时间:week 11
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short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
week 11
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Multiple Sclerosis Impact Scale (MSIS-29)
大体时间:Baseline
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This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100 |
Baseline
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Multiple Sclerosis Impact Scale (MSIS-29)
大体时间:week 11
|
This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100 |
week 11
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Short Form Health survey (SF-36)
大体时间:Baseline
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questionnaire to measure health status.
The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view.
It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
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Baseline
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Short Form Health survey (SF-36)
大体时间:week 11
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questionnaire to measure health status.
The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view.
It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
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week 11
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- B707201835771
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Training intervention + Dance intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人