Wearable Vibration Neuromodulation for Freezing of Gait: A Randomised Controlled Trial

Background: Freezing of gait (FOG) in Parkinson's disease (PD) is provoked by turning, doorways and dual-task walking. We evaluated WALK, a cadence-linked vibration neuromodulation combined with motor-learning training. Methods: Single-centre, sham-controlled pilot randomised trial. Adults with PD (Hoehn and Yahr 2 to 4) and neurologist-verified FOG were randomised 1:1 to intervention (WALK; vibration enabled) or sham (WALK; vibration disabled), alongside identical supervised home-based training for 6 weeks (3 sessions per week). OFF-medication assessments were performed at S0, S8 and S16. At S8 and S16, assessments were completed without a device and then with a device (fixed order). The primary endpoint was the mZ-FOG total (0 to 36). Results: Forty participants completed follow-up assessments (intervention n=24; sham n=16) with 100% session adherence and no serious device-related adverse events. In the intervention group, mZ-FOG total improved when assessed with the device at S8 ({Delta}=8.08) and S16 ({Delta}=9.21) relative to S0, with partial retention when assessed without the device at S16 ({Delta}=5.54). Conclusions: Cadence-linked, localised vibration neuromodulation plus motor-learning training was feasible and was associated with clinically meaningful within-intervention-group reductions in FOG. Taken together, the effect sizes and task-specific pattern support progression to a multicentre, assessor-blinded trial with an active sham, powered for between-group comparisons and durability and/or adherence endpoints.