Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.

Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Diagnostic test: Assessment of walking-related fatigability

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Hasselt University
  • Melsbroek, Belgium, 1820
    • National MS Center Melsbroek
  • Overpelt, Belgium, 3900
    • Revalidatie & MS Centrum Overpelt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Healthy controls	Diagnostic test: Assessment of walking-related 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.
Active Comparator: persons with Multiple Sclerosis (MS)	Diagnostic test: Assessment of walking-related 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deceleration index	Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Inventory Questionnaire	Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT)	day 1
Symptom Inventory Questionnaire	Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT)	day 4
spasticity	Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)	day 1
spasticity	Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)	day 4
Strength	Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)	day 1
Strength	Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)	day 4
Balance	Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)	day 1
Balance	Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)	day 4
VAS fatigue	Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)	day 1
VAS fatigue	Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)	day 4
heart rate	Heart rate pre 6MWT and after each minute of 6MWT	day 1
heart rate	Heart rate pre 6MWT and after each minute of 6MWT	day 4
gait parameter	APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.	day 1
gait parameter	APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.	day 4
Cognitive fatigability	deceleration of reaction time of answers of the Alphabeth vigilance test six minutes while walking and the Alphabeth vigilance test six minutes in rest.	between week 1 and week 2 (no specific day: at the day the patients request)

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Revalidatie & MS Centrum Overpelt; National MS Center Melsbroek
• Investigators: Study Chair: Fanny Van Geel, drs., Hasselt University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Mult Scler. 2021 Feb;27(2):325.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: FaVG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No