G35
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Men, women, and individuals of diverse gender identities with a diagnosis of multiple sclerosis according to the currently valid version of the (revised) McDonald criteria (McDonald et al., 2001; Polman et al., 2011; Thompson et al., 2018; Montalban et al., 2025) • Expanded Disability Status Scale (EDSS) score between 2.0 and 5.5 (Kurtzke, 1983) • Presence of an objectively verifiable functional impairment with functional loss in at least one of the following EDSS Functional Systems: pyramidal (FS 1), cerebellar (FS 2), or sensory (FS 4), defined as an FS score = 2 in at least one of these systems on neurological examination according to Kurtzke • All MS disease courses: relapsing–remitting MS (RRMS) and progressive MS, including primary progressive MS (PPMS) and secondary progressive MS (SPMS) (Vollmer et al., 2021) • Intact cognitive function as determined by specialist neurological examination and a Mini-Mental State Examination (MMSE) score of = 24/30 (Kessler et al., 1990) • Any ethnicity • German language proficiency in spoken and written form
Exclusion criteria
Exclusion criteria: • Any comorbidity which, in the opinion of the investigators, could prevent or adversely affect participation in the study (e.g. malignant disease, other neurological, psychiatric, or severe orthopaedic or rheumatological conditions) • Recent surgical procedures involving the joints or soft tissues of the extremities or the cervical spine, as well as severe osteoarthritis, inflammatory conditions, or pain • Untreated significant impairment of vision or hearing • An MS relapse within the three months prior to study entry or during the study period • In the event of a change in medication that may influence the study outcomes, participants may be excluded from the study at the discretion of the investigators • Women of childbearing potential: pregnancy (confirmed by pregnancy test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensorimotor coordination (1.1 and 1.2): 1.1 Movement frequency measured using the Hand Tapping Test (HTT) and the Foot Tapping Test (FTT) in silence 1.2 Sensorimotor synchronisation measured using the HTT and FTT performed in time with a metronome (90 beats per minute and 110 beats per minute) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2.1 Dynamic balance and coordination during stepping over a low obstacle, measured using the Four Square Step Test (FSST) 2.2 Dynamic balance, measured using the Mini-Balance Evaluation Systems Test (Mini-BESTest) 2.3 Feasibility of the methods and of a randomised controlled trial with adequate statistical power, assessed by eligibility, recruitment, retention, and adherence rates; acceptability (Theoretical Framework of Acceptability [TFA] questionnaire; Smiley Likert scale); and intervention safety (no serious adverse events [SAEs] causally related to the study intervention) 2.4 Gait speed, measured using the Timed 25-Foot Walk (T25FW) 2.5 Gross manual dexterity, measured using the Box and Block Test (BBT) 2.6 Fine manual dexterity, measured using the Nine-Hole Peg Test (NHPT) 2.7 Intrinsic motivation in relation to a specific activity (Body Percussion training or conventional coordination and balance training), measured using the Short Scale of Intrinsic Motivation (KIM) 2.8 Anxiety and depression, measured using the Hospital Anxiety and Depression Scale (HADS) 2.9 Health-related quality of life, reflecting the subjective impact of multiple sclerosis, measured using the Multiple Sclerosis Impact Scale (MSIS-29) Additional outcome: Adverse events (AEs) are monitored, documented, and managed throughout the entire study period | — |
Countries
Austria
Contacts
Reha Zentrum Münster Betriebs GmbH