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Underlying Causes and Related Factors, and Rehabilitation Approaches

28 мая 2020 г. обновлено: Peter Feys, Hasselt University

Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o

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.

Обзор исследования

Статус

Завершенный

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

40

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

      • Hasselt, Бельгия, 3500
        • Hasselt University
      • Liège, Бельгия, 4000
        • Centre Hospitalier Universitaire de Liege

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 70 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Скрининг
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Persons with MS, dance group
Training intervention + Dance intervention
Активный компаратор: Persons with MS, art group
Training intervention + Dance intervention

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
тест модальности символов и цифр (SDMT) (когнитивная утомляемость)
Временное ограничение: неделя 11
Это тест на когнитивные способности, подтвержденный фокусом, скоростью и визуальным сканированием. Правильные ответы за последние 30 секунд по сравнению с первыми 30 секундами
неделя 11
Тест с девятью отверстиями (NHPT)
Временное ограничение: неделя 11
Это двигательный тест для оценки мануальных навыков участника. В этом тесте фиксируется время, необходимое участнику, чтобы поместить 9 булавок в доску и снова удалить их.
неделя 11
the Coordination test
Временное ограничение: 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.
Day 1
TST (Triple Stimulation Technique)
Временное ограничение: day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
day 3
TMS (Transcranial Magnetic Stimulation)
Временное ограничение: Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
Day 3
the Voluntary Drive test
Временное ограничение: 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.
Day 1
the Fatigability Index Legs
Временное ограничение: Day 1
Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
Day 1
Analysis of a Muscle Biopsy
Временное ограничение: Day 3
A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
Day 3
the Digit Span
Временное ограничение: Baseline
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Baseline
the Digit Span
Временное ограничение: Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Week 11
the Stroop test
Временное ограничение: Baseline
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
Baseline
the Stroop test
Временное ограничение: week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
week 11
the Paced Auditory Serial Addition Test (PASAT)
Временное ограничение: Baseline
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
Baseline
the Paced Auditory Serial Addition Test (PASAT)
Временное ограничение: 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
Week 11
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Временное ограничение: Baseline
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Baseline
Motor function test (lower limb muscle strength)
Временное ограничение: Baseline
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.
Baseline
Motor function test (lower limb muscle strength)
Временное ограничение: 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.
week 11
25 Foot Walk (T25FW) test
Временное ограничение: Baseline
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.
Baseline
25 Foot Walk (T25FW) test
Временное ограничение: 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.
week 11
Nine Hole Peg Test (NHPT)
Временное ограничение: Baseline
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.
Baseline
Fatigability Index Hand
Временное ограничение: Baseline
Grip strength will be evaluated through a Jamar dynamometer.
Baseline
Fatigability Index Hand
Временное ограничение: week 11
Grip strength will be evaluated through a Jamar dynamometer.
week 11
Activity tracker
Временное ограничение: 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.
Up to 5 days
Glycocheck
Временное ограничение: 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.
Baseline
Six minute walking test
Временное ограничение: 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.
once during the observational study

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Fatigue severity scale (FSS)
Временное ограничение: baseline
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
baseline
Fatigue severity scale (FSS)
Временное ограничение: week 11
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
week 11
Modified Fatigue Impact Scale (MFIS)
Временное ограничение: baseline
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
baseline
Modified Fatigue Impact Scale (MFIS)
Временное ограничение: week 11
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
week 11
Fatigue Scale of Motor and Cognitive Functions (FSMC)
Временное ограничение: baseline
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.
baseline
Fatigue Scale of Motor and Cognitive Functions (FSMC)
Временное ограничение: week 11
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.
week 11
Hospital Anxiety and Depression Scale (HADS)
Временное ограничение: baseline
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..
baseline
Hospital Anxiety and Depression Scale (HADS)
Временное ограничение: Week 11
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.
Week 11
The Sleep Condition Indicator (SCI)
Временное ограничение: baseline
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.
baseline
The Sleep Condition Indicator (SCI)
Временное ограничение: week 11
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.
week 11
Social Role Participation Questionnaire (SRPQ)
Временное ограничение: baseline
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5(very important)
baseline
Social Role Participation Questionnaire (SRPQ)
Временное ограничение: week 11
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5 (very important)
week 11
pre-interventionMSWS-12 score
Временное ограничение: baseline

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
post-interventionMSWS-12 score
Временное ограничение: baseline

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
pre-interventionMSWS-12 score
Временное ограничение: week 11

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
post-interventionMSWS-12 score
Временное ограничение: week 11

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
Multiple Sclerosis Impact Scale (MSIS-29)
Временное ограничение: Baseline

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
Multiple Sclerosis Impact Scale (MSIS-29)
Временное ограничение: 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
Short Form Health survey (SF-36)
Временное ограничение: Baseline
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.
Baseline
Short Form Health survey (SF-36)
Временное ограничение: week 11
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.
week 11

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Соавторы

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 марта 2019 г.

Первичное завершение (Действительный)

31 декабря 2019 г.

Завершение исследования (Действительный)

31 декабря 2019 г.

Даты регистрации исследования

Первый отправленный

25 октября 2019 г.

Впервые представлено, что соответствует критериям контроля качества

28 октября 2019 г.

Первый опубликованный (Действительный)

29 октября 2019 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 июня 2020 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 мая 2020 г.

Последняя проверка

1 мая 2020 г.

Дополнительная информация

Термины, связанные с этим исследованием

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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