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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Assessment of walking-related fatigability
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hasselt University
  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

persons with Multiple Sclerosis (MS)

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
spasticity
Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)
spasticity
Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)
Strength
Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)
Strength
Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)
Balance
Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)
Balance
Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)
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)
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)
heart rate
Heart rate pre 6MWT and after each minute of 6MWT
heart rate
Heart rate pre 6MWT and after each minute of 6MWT
gait parameter
APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.
gait parameter
APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.
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.

Full Information

First Posted
August 2, 2018
Last Updated
February 28, 2019
Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
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1. Study Identification

Unique Protocol Identification Number
NCT03860675
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
persons with Multiple Sclerosis (MS)
Arm Type
Active Comparator
Arm Title
Healthy controls
Arm Type
Placebo Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of walking-related fatigability
Intervention Description
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.
Primary Outcome Measure Information:
Title
Deceleration index
Description
Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Symptom Inventory Questionnaire
Description
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)
Time Frame
day 1
Title
Symptom Inventory Questionnaire
Description
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)
Time Frame
day 4
Title
spasticity
Description
Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)
Time Frame
day 1
Title
spasticity
Description
Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)
Time Frame
day 4
Title
Strength
Description
Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)
Time Frame
day 1
Title
Strength
Description
Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)
Time Frame
day 4
Title
Balance
Description
Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)
Time Frame
day 1
Title
Balance
Description
Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)
Time Frame
day 4
Title
VAS fatigue
Description
Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)
Time Frame
day 1
Title
VAS fatigue
Description
Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)
Time Frame
day 4
Title
heart rate
Description
Heart rate pre 6MWT and after each minute of 6MWT
Time Frame
day 1
Title
heart rate
Description
Heart rate pre 6MWT and after each minute of 6MWT
Time Frame
day 4
Title
gait parameter
Description
APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.
Time Frame
day 1
Title
gait parameter
Description
APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.
Time Frame
day 4
Title
Cognitive fatigability
Description
deceleration of reaction time of answers of the Alphabeth vigilance test six minutes while walking and the Alphabeth vigilance test six minutes in rest.
Time Frame
between week 1 and week 2 (no specific day: at the day the patients request)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fanny Van Geel, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Facility Name
National MS Center Melsbroek
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
Revalidatie & MS Centrum Overpelt
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33534273
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.
Results Reference
derived
PubMed Identifier
31496362
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. Erratum In: Mult Scler. 2021 Feb;27(2):325.
Results Reference
derived

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

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