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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Diagnostic Test: Assessment of walking-related fatigability


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: persons with Multiple Sclerosis (MS)<br> | Diagnostic Test: Assessment of walking-related fatigability<br>* 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.<br>|
| Placebo Comparator: Healthy controls<br> | Diagnostic Test: Assessment of walking-related fatigability<br>* 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.<br>|

What is the study measuring?
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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) |