Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Hasselt University
- Enrollment
- 85
- Locations
- 3
- Primary Endpoint
- Deceleration index
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Peter Feys
Principal Investigator
Hasselt University
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)
Outcomes
Primary Outcomes
Deceleration index
Time Frame: day 1
Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%
Secondary Outcomes
- Symptom Inventory Questionnaire(day 4)
- spasticity(day 4)
- Strength(day 4)
- Balance(day 4)
- VAS fatigue(day 4)
- gait parameter(day 4)
- Cognitive fatigability(between week 1 and week 2 (no specific day: at the day the patients request))
- heart rate(day 4)