Abstract / Summary
Background: Freezing of gait (FOG) in Parkinson disease often persists despite dopaminergic treatment. WALK is a bilateral thigh-worn device that delivers local muscle-tendon vibration during walking. We examined whether WALK could be incorporated into supervised home rehabilitation and explored differences in freezing severity between active and sham treatment. Methods: In this single-centre pilot randomised clinical trial, adults with Parkinson disease and neurologist-confirmed FOG were assigned to Active or Sham-WALK. Both groups completed the same 16-session, six-week supervised home programme; mZ-FOG was assessed in the medication OFF state at baseline and after sessions 8 and 16. At each follow-up, assessment without the device preceded assessment with the assigned device. The complete-case analysis tested the Group X Condition interaction across the five conditions. Trial registration: Clinical Trials Registry-India, CTRI/2022/01/039256, https://ctri.nic.in/; registered 7 January 2022. Results: Ninety people were screened, 47 were randomised (active, n=27; sham, n=20), and 40 completed follow-up and entered the main analysis (active, n=24; sham, n=16). Retention was 85.1% (95% CI 74.9% to 95.4%), and all completers finished the 16-session programme. No serious device-related adverse event was reported among completers; one active-group participant discontinued because of fatigue. mZ-FOG scores decreased in both groups, but the Group X Condition interaction was not significant (F=0.847, p=0.465). At S16 before device reapplication, the baseline-adjusted active-minus-sham difference was -2.98 points (95% CI -6.63 to 0.66; p=0.106); with the assigned device, it was -2.87 points (95% CI -6.76 to 1.02; p=0.144). In the Active-WALK group, 18 of 24 improved by at least the 4.28-point MCID. Conclusion: WALK was feasible to integrate into supervised home rehabilitation and was associated with improvement in freezing across training. The lower active-group score before device reapplication at S16 suggests that improvement may have extended beyond the period of immediate stimulation.