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

NCT03860675 | Completed

• 1 other identifier: FaVG-001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

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. 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. 2.What are associated symptoms of walking-related motor fatigability and how long does this manifest?
3. 3.What is the relationship between cognitive fatigability and walking-related performance fatigability?

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Deceleration index

  Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%

  day 1

Secondary Outcomes (15)

• Symptom Inventory Questionnaire

  day 1

• Symptom Inventory Questionnaire

  day 4

• spasticity

  day 1

• spasticity

  day 4

• Strength

  day 1

Study Arms (2)

persons with Multiple Sclerosis (MS)

ACTIVE COMPARATOR

Diagnostic Test: Assessment of walking-related fatigability

Healthy controls

PLACEBO COMPARATOR

Diagnostic Test: Assessment of walking-related fatigability

Interventions

Assessment of walking-related fatigability DIAGNOSTIC_TEST

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.

Healthy controls; persons with Multiple Sclerosis (MS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator
• National MS Center Melsbroek: collaborator

Study Sites (3)

Hasselt University

Diepenbeek, 3590, Belgium

Location

National MS Center Melsbroek

Melsbroek, 1820, Belgium

Location

Revalidatie & MS Centrum Overpelt

Overpelt, 3900, Belgium

Location

Related Publications (2)

• 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.

  PMID: 33534273 DERIVED

• 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.

  PMID: 31496362 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Fanny Van Geel, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: March 4, 2019
• Study Start: December 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02

Locations

BE (3)