Multiple Sclerosis Nervous System Diseases Multiple Sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Ambulatory multiple sclerosis (MS) patients fulfulling the following enrollment criteria: 1. Age between 18-70 years 2. Diagnosis of MS according to the criteria of McDonald 3. Able to walk with no more than one unilateral walking aid i.e. able to walk with no more than one unilateral walking aid 4. Suffering from fatigue, defined as a score higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS)
Exclusion criteria
Exclusion criteria: 1. Patients using in the last three months prior to inclusion amantadine, modafinil, Ritalin® or pemoline for their fatigue 2. Major depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Fatigue: Checklist Individual Strength (CIS) subscale fatigue 2. Participation: Impact on Participation and Autonomy (IPA) The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medical Outcome study Short Form 36 (SF36) 2. Rehabilitation Activities Profile (RAP) 3. Fatigue Severity Scale (FSS) 4. Checklist Individual Strength (CIS) subscales motivation, concentration, activity 5. Modified Fatigue Impact Scale (MFIS) The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52 | — |
Countries
Netherlands