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Underlying Causes and Related Factors, and Rehabilitation Approaches

28. maj 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Persons with MS, dance group
Training intervention + Dance intervention
Aktiv komparator: Persons with MS, art group
Training intervention + Dance intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symbol Digit Modality Test (SDMT) (Kognitiv træthed)
Tidsramme: uge 11
hans er en kognitiv præstationstest, underbygget med fokus, hastighed og visuel scanning. Korrekte svar sidste 30 sekunder vs første 30 sekunder
uge 11
Ni-hullers peg-test (NHPT)
Tidsramme: uge 11
Dette er en motorisk test for at vurdere deltagerens manuelle færdigheder. Denne test registrerer den tid, deltageren skal bruge for at placere 9 stifter i pegboardet og fjerne dem igen.
uge 11
the Coordination test
Tidsramme: 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)
Tidsramme: day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
day 3
TMS (Transcranial Magnetic Stimulation)
Tidsramme: Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
Day 3
the Voluntary Drive test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Baseline
the Digit Span
Tidsramme: Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Week 11
the Stroop test
Tidsramme: Baseline
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
Baseline
the Stroop test
Tidsramme: week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
week 11
the Paced Auditory Serial Addition Test (PASAT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline
Grip strength will be evaluated through a Jamar dynamometer.
Baseline
Fatigability Index Hand
Tidsramme: week 11
Grip strength will be evaluated through a Jamar dynamometer.
week 11
Activity tracker
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2019

Primær færdiggørelse (Faktiske)

31. december 2019

Studieafslutning (Faktiske)

31. december 2019

Datoer for studieregistrering

Først indsendt

25. oktober 2019

Først indsendt, der opfyldte QC-kriterier

28. oktober 2019

Først opslået (Faktiske)

29. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Training intervention + Dance intervention

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