Clinical trial NCT04142853: Underlying Causes and Related Factors, and Rehabilitation Approaches
Official title: Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: University of Liege
First posted: 2019-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: the Coordination test
timeFrame: Day 1
measure: TST (Triple Stimulation Technique)
timeFrame: day 3
measure: TMS (Transcranial Magnetic Stimulation)
timeFrame: Day 3
measure: the Voluntary Drive test
timeFrame: Day 1
measure: the Fatigability Index Legs
timeFrame: Day 1
measure: Analysis of a Muscle Biopsy
timeFrame: Day 3
measure: the Digit Span
timeFrame: Baseline
measure: the Digit Span
timeFrame: Week 11
measure: the Stroop test
timeFrame: Baseline
measure: the Stroop test
timeFrame: week 11
measure: the Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline
measure: the Paced Auditory Serial Addition Test (PASAT)
timeFrame: Week 11
measure: the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
timeFrame: Baseline
measure: the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
timeFrame: week 11
measure: Motor function test (lower limb muscle strength)
timeFrame: Baseline
measure: Motor function test (lower limb muscle strength)
timeFrame: week 11
measure: 25 Foot Walk (T25FW) test
timeFrame: Baseline
measure: 25 Foot Walk (T25FW) test
timeFrame: week 11
measure: Nine Hole Peg Test (NHPT)
timeFrame: Baseline
measure: Nine Hole Peg Test (NHPT)
timeFrame: week 11
measure: Fatigability Index Hand
timeFrame: Baseline
measure: Fatigability Index Hand
timeFrame: week 11
measure: Activity tracker
timeFrame: Up to 5 days
measure: Glycocheck
timeFrame: Baseline
measure: Six minute walking test
timeFrame: once during the observational study
Secondary outcomes:
measure: Fatigue severity scale (FSS)
timeFrame: baseline
measure: Fatigue severity scale (FSS)
timeFrame: week 11
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: week 11
measure: Fatigue Scale of Motor and Cognitive Functions (FSMC)
timeFrame: baseline
measure: Fatigue Scale of Motor and Cognitive Functions (FSMC)
timeFrame: week 11
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 11
measure: The Sleep Condition Indicator (SCI)
timeFrame: baseline
measure: The Sleep Condition Indicator (SCI)
timeFrame: week 11
measure: Social Role Participation Questionnaire (SRPQ)
timeFrame: baseline
measure: Social Role Participation Questionnaire (SRPQ)
timeFrame: week 11
measure: pre-interventionMSWS-12 score
timeFrame: baseline
measure: post-interventionMSWS-12 score
timeFrame: baseline
measure: pre-interventionMSWS-12 score
timeFrame: week 11
measure: post-interventionMSWS-12 score
timeFrame: week 11
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Baseline
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: week 11
measure: Short Form Health survey (SF-36)
timeFrame: Baseline
measure: Short Form Health survey (SF-36)
timeFrame: week 11
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
Study officials:
References:
citation: Goetschalckx M, Van Geel F, Meesen R, Triccas LT, Geraerts M, Moumdjian L, Feys P. Interlimb Coordination Performance in Seated Position in Persons With Multiple Sclerosis: Reduced Amplitude Over 6 min and Higher Coordination Variability in Persons With Walking Fatigability. Front Hum Neurosci. 2021 Oct 20;15:765254. doi: 10.3389/fnhum.2021.765254. eCollection 2021.