G35
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: MS diagnosis according to Lublin criteria confirmed by a medical doctor. No contraindications against treadmill training. No other neurological or psychiatric illness that limit comprehension of the study protocol and/ or to give an informed consent, understanding test- and/ or training instructions, and safety concerns. Moreover patients must not have illnesses that cause concurrent cognitive and/ or motor impairment have. Patients are able and willing to provide a written informed consent.
Exclusion criteria
Exclusion criteria: Continuously changing medication. insufficient knowledge of the German language to follow test- and/ or training instructions. Uncorrected auditory or visual impairment. Severe cognitive impairment (criteria: Montreal Cognitive Assessment (MoCA) > 17 points; Freitas et al., 2014). Scheduled length of stay of less than 14 days, which would not allow completing the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptance: Participation rate (% of participating patiens in relation to eligible patients, constant documentation, evaluation in the final analysis), training-adherence-rate (% of absolved trainings in relation to scheduled trainings, constant documentation, evaluation in the final analysis), completion-rate (% of completing patients in relation to included patients, constant documentation, evaluation in the final analysis), adverse events (eg. falls/ almost falls, training abortions due to motor or cognitive exhaustion as well as training induced unwell-being or pain, constant documentation, evaluation in the final analysis) Feasibility: Rehab goals (Goal Attainment Scale, T0), Usability of the training (System Usability Scale, T1), relevance of the training to achieve personal goals (4-level Likert Scales to rate how far the goals set at T0 were achieved during training, T1), patients’ rating of the training concerning motivation, mood, fun, and exhaustion (4-level Likert Scales, daily (motivation and mood rated before training, fun and exhaustion are rated after training), ability to synchronize steps to metronome/ music (video evaluation on daily base rating percentage of steps in synchronization with the beat, overall percentage used in the final analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognition (processing speed (TAP), attention(TAP), flexibility (TAP), inhibition (TAP), visuo-cognition (TAP), verbal and non-verbal memory (WMS-R), working memory (WMS-R), word finding ability (GFWF)) Motor function (hand function (NHPT), walking speed (T25FW), steps/ min, safety of gait (TUG), dual-task gait (DTGT), balance (BBS), walking endurance (6MinWT)) clinical data (fatigue (FSMC), depression (ADS), fear of falling (FES-I, SAFFE, ABC), physical activity level (IPAQ), functional independence (FIM), quality of life (MSQOL-54)) | — |
Countries
Germany
Contacts
Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.