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Underlying Causes and Related Factors, and Rehabilitation Approaches

2020年5月28日 更新者: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.

調査の概要

研究の種類

介入

入学 (実際)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Hasselt、ベルギー、3500
        • Hasselt University
      • Liège、ベルギー、4000
        • Centre Hospitalier Universitaire de Liege

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~70年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Persons with MS, dance group
Training intervention + Dance intervention
アクティブコンパレータ:Persons with MS, art group
Training intervention + Dance intervention

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Symbol Digit Modality Test (SDMT) (認知疲労度)
時間枠:11週目
これは認知能力テストであり、焦点、速度、および視覚的スキャンで実証されています。 正解の最後の 30 秒と最初の 30 秒
11週目
9 穴ペグ テスト (NHPT)
時間枠:11週目
これは、参加者のマニュアル スキルを評価するモーター テストです。 このテストでは、参加者が 9 本のピンをペグボードに配置し、再び取り外す必要がある時間を記録します。
11週目
the Coordination test
時間枠: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)
時間枠:day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
day 3
TMS (Transcranial Magnetic Stimulation)
時間枠:Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
Day 3
the Voluntary Drive test
時間枠: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
時間枠: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
時間枠: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
時間枠:Baseline
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Baseline
the Digit Span
時間枠:Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Week 11
the Stroop test
時間枠:Baseline
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
Baseline
the Stroop test
時間枠:week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
week 11
the Paced Auditory Serial Addition Test (PASAT)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠:Baseline
Grip strength will be evaluated through a Jamar dynamometer.
Baseline
Fatigability Index Hand
時間枠:week 11
Grip strength will be evaluated through a Jamar dynamometer.
week 11
Activity tracker
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Fatigue severity scale (FSS)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠:baseline
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5(very important)
baseline
Social Role Participation Questionnaire (SRPQ)
時間枠:week 11
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5 (very important)
week 11
pre-interventionMSWS-12 score
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年3月1日

一次修了 (実際)

2019年12月31日

研究の完了 (実際)

2019年12月31日

試験登録日

最初に提出

2019年10月25日

QC基準を満たした最初の提出物

2019年10月28日

最初の投稿 (実際)

2019年10月29日

学習記録の更新

投稿された最後の更新 (実際)

2020年6月1日

QC基準を満たした最後の更新が送信されました

2020年5月28日

最終確認日

2020年5月1日

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米国FDA規制機器製品の研究

いいえ

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