Healthy subjects G35
Conditions
Interventions
Group 1: Observation group:
Adults (n = 20) aged 18-60 years with a confirmed diagnosis of MS and an EDSS of no more than 4.5 are included in the study. Recruitment takes place at the Schmieder Klinik
Sponsors
Otto-von-Guericke Universität Magdeburg, Institut III, Bereich Sportwissenschaft
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria multiple sclerosis patients: - 18-60 years - secured MS diagnosis according to the revised McDonald criteria of 2010 (Polman et al., 2011) - Expanded Disability Status Scale (EDSS) 0-4.5 or walking ability of at least 200 m 2. Inclusion criteria healthy control group: - 18-60 years - No orthopedic or neurological diseases - Unlimited walking ability
Exclusion criteria
Exclusion criteria: 1. MS: - less than 30 days after acute attack or last cortisone intake - visual disturbances - aphasia - epilepsy 2. Healthy Controls: - neurological and orthopaedic limitations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, a portable fNIRS system (NIRSport, NIRx Medical Technologies, NY, USA) will be used to assess the hemodynamic response of the prefrontal cortex. The exact areas captured are the right and left dorsolateral prefrontal cortex (DLPFC) (Brodmann area (BA) 9&46), the right and left frontopolar cortex (FPC) (BA10) and the right and left pars triangularis of the Broca areal (BA45). Therefore, the primary outcome is the oxyHb and the deoxyHb concentrations in those areas. Capturing fatigability is still challenging as there is a lack of reference data. Hence, we will use two different methods to make a rough categorization of whether patients have fatigability or not. The first method is the modified 6-min walking test Leone et al. 2016. Here, care will be taken not only to record the distance of the entire six minutes, but also the distance of every single minute. Based on these values the “distance walked index (DWI=([distance walked at minute n-distance walked at minute1]/distance walked at minute1)×100)” (Leone et al. 2016) will be calculated. The second method to categorize will be the expert meaning that is predicated on the videos made during the measurements (GoPro Hero 4, GoPro Inc., CA, USA). Based on predefined criteria, the videos will be evaluated for indications of fatigability by two independent observers (health professionals). In order to not only record the hemodynamic response with the fNIRS, but also to be able to assess whether motor changes occur during the measurements, a standard gait analysis will be performed. Here, the outcome parameters of interest are double step length (DSL), gait velocity and the minimum toe clearance (MTC) as they are all indicators for a stable gait pattern. | — |
Secondary
| Measure | Time frame |
|---|---|
| As complementary information, the socio-demographic (age and sex), anthropometric (height and weight) and disease-specific data (years since first onset of the disease, years since first diagnosis of the disease, MS-type and expanded disability status scale (EDSS)) will be listed for all patients. Before the measurements take place, the patients have to fill out two questionnaires. First, we will evaluate the patients’ self-report of their walking abilities by using the German version of the MSWS-12. The second questionnaire, the German version of the “Fatigue Scale for Motor and Cognitive function” (Penner et al. 2009), is designed to estimate the subjective level of Fatigue. Additionally, the subjective exertion will be queried with the Borg scale before and after the measurements. During the entire measurement, the pulse, blood pressure, peripheral oxygen supply and heart rate variability are recorded by the SOMNOwatch. | — |
Countries
Germany
Contacts
Public ContactKim-Charline Broscheid
Otto-von-Guericke Universität Magdeburg Bereich Sportwissenschaft
Outcome results
None listed