Multiple Sclerosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTAssessment of walking-related 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.
Sponsors
Revalidatie & MS Centrum Overpelt
National MS Center Melsbroek
Hasselt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deceleration index | day 1 | Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| spasticity | day 1 | Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT) |
| Strength | day 1 | Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT) |
| Balance | day 1 | Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT) |
| Symptom Inventory Questionnaire | day 1 | 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) |
| heart rate | day 1 | Heart rate pre 6MWT and after each minute of 6MWT |
| gait parameter | day 1 | 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. |
| VAS fatigue | day 1 | Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10) |
Countries
Belgium
Outcome results
None listed