이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Underlying Causes and Related Factors, and Rehabilitation Approaches

2020년 5월 28일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Persons with MS, dance group
Training intervention + Dance intervention
활성 비교기: Persons with MS, art group
Training intervention + Dance intervention

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
SDMT(Symbol Digit Modality Test)(인지 피로도)
기간: 11주차
그의 인지 성능 테스트는 초점, 속도 및 시각적 스캐닝으로 입증됩니다. 정답은 30초 지속 vs 처음 30초
11주차
9홀 페그 테스트(NHPT)
기간: 11주차
이것은 참가자의 수동 기술을 평가하기 위한 운동 테스트입니다. 이 테스트는 참가자가 페그보드에 9개의 핀을 배치하고 다시 제거하는 데 필요한 시간을 기록합니다.
11주차
the Coordination test
기간: 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)
기간: day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
day 3
TMS (Transcranial Magnetic Stimulation)
기간: Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
Day 3
the Voluntary Drive test
기간: 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
기간: 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
기간: 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
기간: Baseline
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Baseline
the Digit Span
기간: Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Week 11
the Stroop test
기간: Baseline
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
Baseline
the Stroop test
기간: week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
week 11
the Paced Auditory Serial Addition Test (PASAT)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: Baseline
Grip strength will be evaluated through a Jamar dynamometer.
Baseline
Fatigability Index Hand
기간: week 11
Grip strength will be evaluated through a Jamar dynamometer.
week 11
Activity tracker
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Fatigue severity scale (FSS)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: baseline
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5(very important)
baseline
Social Role Participation Questionnaire (SRPQ)
기간: week 11
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5 (very important)
week 11
pre-interventionMSWS-12 score
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 3월 1일

기본 완료 (실제)

2019년 12월 31일

연구 완료 (실제)

2019년 12월 31일

연구 등록 날짜

최초 제출

2019년 10월 25일

QC 기준을 충족하는 최초 제출

2019년 10월 28일

처음 게시됨 (실제)

2019년 10월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 5월 28일

마지막으로 확인됨

2020년 5월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다