Clinical trial NCT03860675: Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.
Official title: Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: National MS Center Melsbroek
First posted: 2019-03-04
Enrollment: 85
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: The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability.

The following three research questions will be addressed:

1. How prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure?
2. What are associated symptoms of walking-related motor fatigability and how long does this manifest?
3. What is the relationship between cognitive fatigability and walking-related performance fatigability?

participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.


Eligibility criteria: Inclusion Criteria:

* Age between 18 - 70 years
* Confirmed diagnosis according to the McDonald criteria
* Performed a 6MWT before, to ensure familiarization
* Able to walk independently or with unilateral support for 6 minutes without rest
* Signed the informed consent

Exclusion Criteria:

* Exacerbation or relapse within last 3 months before study
* Other neurological diagnosis, such as stroke and Parkinson
* MS-like syndromes, such as neuromyelitis optica
* Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)

Primary outcomes:
measure: Deceleration index
timeFrame: day 1
Secondary outcomes:
measure: Symptom Inventory Questionnaire
timeFrame: day 1
measure: Symptom Inventory Questionnaire
timeFrame: day 4
measure: spasticity
timeFrame: day 1
measure: spasticity
timeFrame: day 4
measure: Strength
timeFrame: day 1
measure: Strength
timeFrame: day 4
measure: Balance
timeFrame: day 1
measure: Balance
timeFrame: day 4
measure: VAS fatigue
timeFrame: day 1
measure: VAS fatigue
timeFrame: day 4
measure: heart rate
timeFrame: day 1
measure: heart rate
timeFrame: day 4
measure: gait parameter
timeFrame: day 1
measure: gait parameter
timeFrame: day 4
measure: Cognitive fatigability
timeFrame: between week 1 and week 2 (no specific day: at the day the patients request)
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
city: Melsbroek
country: Belgium
facility: National MS Center Melsbroek
city: Overpelt
country: Belgium
facility: Revalidatie & MS Centrum Overpelt
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Fanny Van Geel, drs.
role: STUDY_CHAIR
References:
citation: Van Geel F, Bielen H, Theunissen K, Moumdjian L, Van Nieuwenhoven J, Van Wijmeersch B, Meesen R, Ramari C, Feys P. Clinical manifestation and perceived symptoms of walking-related performance fatigability in persons with multiple sclerosis. Int J Rehabil Res. 2021 Jun 1;44(2):118-125. doi: 10.1097/MRR.0000000000000457.
citation: Van Geel F, Veldkamp R, Severijns D, Dalgas U, Feys P. Day-to-day reliability, agreement and discriminative validity of measuring walking-related performance fatigability in persons with multiple sclerosis. Mult Scler. 2020 Nov;26(13):1785-1789. doi: 10.1177/1352458519872465. Epub 2019 Sep 9.