Abstract
BACKGROUND: Oscillatory whole-body vibration (WBV) training improves strength and movement skills in healthy adults and individuals with various medical conditions. Studies examining the effects of WBV on gait disorder in people with multiple sclerosis (PwMS) of progressive disease form (progressive MS (PMS)), however, produced inconsistent results. OBJECTIVES: To assess the feasibility and explore effects of WBV training on spastic gait in PwMS. DESIGN AND METHODS: Single-centre randomised, single-blind, pilot study involving 30 PwMS with mild-to-moderate spastic gait disorder (Expanded Disability Status Scale (EDSS) 3.0-6.5). Patients were randomised 1:1 into arm 1 (12-week standard-of-care before WBV) and arm 2 (immediate WBV). WBV was delivered using a side-alternating Galileo Med 25 TT platform as a home-training programme, complemented by a standardised exercise protocol. The primary endpoint was the 6-minute walking distance (6MWD). RESULTS: The distribution between arms concerning age, sex, body mass index, EDSS and baseline 6MWD was balanced. Adherence to the protocol was similar across both arms, with 70% of all patients completing all three study visits, with four dropouts per arm. Efficacy analyses included participants completing ≥50% of WBV sessions, comprising 17 participants (57%). 67% of all participants experienced AEs, which were equally distributed across both groups and not severe. Participant satisfaction with the intervention was high, with 70% indicating willingness to repeat the training. After 12 weeks of WBV training, a non-significant numerical increase in median 6MWD was observed. Patient-reported spasticity, assessed using the MSSS88 (Multiple Sclerosis Spasticity Scale), showed a non-significant numerical decrease following WBV. CONCLUSIONS: In this exploratory pilot study, we could demonstrate feasibility of a WBV intervention study in PwMS. As only 57% of the participants were able to complete the per-protocol training specifications, larger studies that intend to explore the efficacy of the WBV intervention in PMS should consider a less ambitious and a more individualised training protocol. TRIAL REGISTRATION NUMBER: DRKS00022962.