G35
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -EDSS (Expanded Disability Status Scale): =5.0 -FSMC total score: =53 -MS phenotype: relapsing-remitting, secondary-progressive -Written informed consent
Exclusion criteria
Exclusion criteria: -Unable to attend water therapy -Comorbidities that prevent attending study therapies -German language skills that interfere with understanding of testing and instructions -Current fatigue medication (Amantadin, Modafinil) started <3 months ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue 1. Würzburger Erschöpfungsinventar bei Multipler Sklerose (WEIMuS) [Timepoints: admission, discharge, one, four and 12 weeks after discharge] 2. Fatigue Scale for Motor and Cognitive Functions (FSMC) [Timepoints: admission, discharge, one, four and 12 weeks after discharge] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Cognitive fatigability (Test Battery of Attention Performance – Alertness) [Timepoints: admission, discharge] 2. Motor fatigability (6-minute walk test) [Timepoints: admission, discharge] 3. Cognitive performance (California Verbal Learning Test; Symbol Digit Modalities Test) [Timepoints: admission, discharge] 4. Cardiorespiratory fitness (predicted relative peak oxygen uptake) [Timepoints: admission, discharge] 5. Motor function (Six Spot Step Test; Functional Gait Assessment; Timed 25-foot Walk Test) [Timepoints: admission, discharge] 6. Balance confidence (Activities-Specific Balance Confidence Scale) [Timepoints: admission, discharge] Feasibility outcomes 1. Process (eligibility criteria, recruitment, retention, and refusal rates, adherence, fidelity) 2. Resources (days at baseline assessments, time requirements) 3. Data management (missing items WEIMuS+FSMC, missing assessments at admission and discharge) 4. Acceptability of interventions (adverse events, estimation of treatment effect, session-Rated Perceived Exertion, fun, relevance) 5. Semi-structured interview (study processes, experiences with interventions) | — |
Countries
Germany
Contacts
Neurologisches Rehabilitationszentrum Godeshöhe e.V.