Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT03860675
- Lead Sponsor
- Hasselt University
- 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:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Deceleration index day 1 Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%
- Secondary Outcome Measures
Name Time Method Symptom Inventory Questionnaire day 4 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 day 4 Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)
Strength day 4 Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)
Balance day 4 Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)
VAS fatigue day 4 Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)
gait parameter day 4 APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.
Cognitive fatigability between week 1 and week 2 (no specific day: at the day the patients request) deceleration of reaction time of answers of the Alphabeth vigilance test six minutes while walking and the Alphabeth vigilance test six minutes in rest.
heart rate day 4 Heart rate pre 6MWT and after each minute of 6MWT
Trial Locations
- Locations (3)
Hasselt University
🇧🇪Diepenbeek, Belgium
National MS Center Melsbroek
🇧🇪Melsbroek, Belgium
Revalidatie & MS Centrum Overpelt
🇧🇪Overpelt, Belgium
Hasselt University🇧🇪Diepenbeek, Belgium