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Multiple SclerosisNCT03860675

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

A study testing Assessment of walking-related fatigability in people with Multiple Sclerosis, run by Hasselt University at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Assessment of walking-related fatigability
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
3 sitesBelgium
Study dates
1 Dec 2017to 31 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Hasselt University

    Diepenbeek, 3590

  • National MS Center Melsbroek

    Melsbroek, 1820

  • Revalidatie & MS Centrum Overpelt

    Overpelt, 3900

Other trials in Belgium

About this study

Official title: 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.
Being tested
Assessment of walking-related fatigability
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of walking-related fatigabilityDiagnostic 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.

Study groups in NCT03860675
Study groupRoleWhat they receive
persons with Multiple Sclerosis (MS)Active comparatorNot described
Receives: Diagnostic Test: Assessment of walking-related fatigability
Healthy controlsPlacebo comparatorNot described
Receives: Diagnostic Test: Assessment of walking-related fatigability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deceleration index

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

    Measured: day 1

Secondary outcomes (15)

  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)

    Measured: day 1

  2. 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)

    Measured: day 4

  3. spasticity

    Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)

    Measured: day 1

  4. spasticity

    Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)

    Measured: day 4

  5. Strength

    Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)

    Measured: day 1

  6. Strength

    Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)

    Measured: day 4

  7. Balance

    Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)

    Measured: day 1

  8. Balance

    Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)

    Measured: day 4

  9. 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)

    Measured: day 1

  10. 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)

    Measured: day 4

  11. heart rate

    Heart rate pre 6MWT and after each minute of 6MWT

    Measured: day 1

  12. heart rate

    Heart rate pre 6MWT and after each minute of 6MWT

    Measured: day 4

  13. gait parameter

    APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.

    Measured: day 1

  14. gait parameter

    APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.

    Measured: day 4

  15. 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.

    Measured: between week 1 and week 2 (no specific day: at the day the patients request)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start1 Dec 2017
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03860675
Sponsor's protocol ID
FaVG-001
Status last verified
Feb 2019
First submitted
2 Aug 2018
Last updated
4 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33534273

  • 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.

    PubMed 31496362

Questions about this trial

What is this clinical trial studying?

A study testing Assessment of walking-related fatigability in people with Multiple Sclerosis, run by Hasselt University at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deceleration index (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860675, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.

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