NCT04803565

The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects

The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the efficacy of custom-made shoe insoles, for subjects with Parkinson's Disease (PD). To do that, a sample of PD subjects has been randomly assigned to an intervention group that will receive the custom-made insoles or a control group that will receive a sham insole without any specific manufacturing. Both groups will receive Physiotherapy and Occupational Therapy according to PD rehabilitation guidelines. The principal outcome will be the Time Up\&Go test time, secondary outcomes 10 Meters Walking test speed, Berg Balance Scale score, SF12 score, and orthesis liking.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Custom-made shoe insole	Subjects will receive a custom-made shoe insole designed on the patient's foot and shoes. The subjects should wear the insole for at least 6 hours per day.
DEVICE	Sham conventional Insole	Subjects will receive a conventional insole without any specific property (sham insole)

Timeline

• Start date: 2021-03-04
• Primary completion: 2022-12-31
• Completion: 2023-03-30
• First posted: 2021-03-17
• Last updated: 2023-10-03

Locations

1 site across 1 country: Italy