The Effect of Personalized Shoe Insoles on Parkinson's Disease Subjects: A Triple-Blind Randomized Controlled Trial.

Subjects with Parkinson's Disease (PD) display different motor and non-motor symptoms. Different therapies have been shown to be effective, such as plantar foot stimulation, which has proved to be effective for motor symptoms. Different stimulation methods were proposed and tested through specific devices, or insoles. Our aim was to assess the effect of a newly designed custom-made insole called PRO-STEP compared with a flat sham insole on subjects with PD. Subjects were randomized 1:1 into two arms and were asked to wear PRO-STEP or sham insoles for at least 6 h per day for 10 weeks. Participants were evaluated at four timepoints. Forty-two subjects were randomly assigned to the PRO-STEP (EG) or sham group (SG). The comparison of the EG and SG without and with insoles (T0-T1) did not show significant differences in the TUG time and in the 10MWT gait parameters. At T1, T2, and T3 TUG time, BBS, SF12-MC, and SF12-PC did not show significant differences. The satisfaction level with the PRO-STEP or sham insoles was high in both groups. PD patients were satisfied with PRO-STEP insoles; however, plantar foot stimulation is not effective from a functional perspective. Future studies should consider possible modifications to the proposed stimulation to improve its effectiveness in patients with PD.