Feasibility and Preliminary Efficacy of Wearable Focal Vibration Therapy on Gait and Mobility in People with Multiple Sclerosis: A Pilot Study.

Abstract

Multiple sclerosis (MS) is a chronic disease of the central nervous system that significantly impairs gait and mobility, contributing to a high risk of falls, reduced participation in daily activities, and diminished quality of life. Despite existing interventions such as exercise programs and pharmacological treatments, challenges such as fatigue, pain, and limited accessibility underscore the need for alternative therapies. Focal vibration therapy (FVT) has shown promise in improving gait, reducing spasticity, and enhancing mobility in people with MS (PwMS). However, further research is required to evaluate its long-term feasibility and optimize its parameters. This study examined the feasibility and preliminary efficacy of a home-based four-week wearable FVT device on gait and explored how FVT parameters impact gait and mobility outcomes. In this pilot double-blind randomized controlled trial, 22 PwMS were randomized into control and vibration groups (four FVT groups with varying vibration intensities/durations). Participants wore Myovolt^® vibrators on distal quadricep muscles near the rectus femoris insertion (approximately 2 cm from the medial edge of the patella), gastrocnemius/soleus, and tibialis anterior muscles (10 min/muscle, 3 days/week, 4 weeks). Feasibility was evaluated via adherence and satisfaction (QUEST 2.0, interviews). Gait (3D motion analysis) and mobility (T25FW) were assessed at baseline and post-intervention. Data were analyzed using descriptive/inferential statistics and thematic analysis. Of 22 participants, 17 completed post-intervention (16 intervention, 1 control). Wearable FVT showed promising feasibility, with high satisfaction despite minor adjustability issues. Intervention groups improved gait speed (p = 0.014), stride length (p = 0.004), and ankle angle (p = 0.043), but T25FW was unchanged (p > 0.05). High-intensity FVT enhanced knee/hip moments. This study's results support the feasibility of wearable FVT for home-based management of mobility symptoms in MS with high participant satisfaction and acceptance. Notable gains in gait parameters suggest FVT's potential to enhance neuromuscular control and proprioception but may be insufficient to lead to mobility improvements. Subgroup analyses highlighted the impact of vibration intensity and duration on knee joint mechanics, emphasizing the need for personalized dosing strategies. Challenges included participant retention in the control group and burdensome biomechanical assessments, which will be addressed in future studies through improved sham devices and a larger sample size.