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

Hasselt University85 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

Hasselt University

Diepenbeek, Belgium

National MS Center Melsbroek

Melsbroek, Belgium

Revalidatie & MS Centrum Overpelt

Overpelt, Belgium

Outcomes

Primary Outcomes

Deceleration index

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

Time frame: day 1

Secondary Outcomes

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)

Time frame: day 1

Symptom Inventory Questionnaire

Time frame: day 4

spasticity

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

Time frame: day 1

spasticity

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

Time frame: day 4

Strength

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

Time frame: day 1

Strength

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

Time frame: day 4

Balance

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

Time frame: day 1

Balance

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

Time frame: 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)

Time frame: 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)

Time frame: day 4

heart rate

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

Time frame: day 1

heart rate

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

Time frame: day 4

gait parameter

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

Time frame: day 1

gait parameter

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

Time frame: 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.

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

Data from ClinicalTrials.gov

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