NCT05998265

A Randomised, Controlled, Open-Label, Multi-Centre Study to Evaluate the Efficacy of FeetMe® Home-Bases Rehabilitation Program in Comparison to Conventional Physiotherapy in Patients With Parkinson's Disease Using Connected Insoles

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: FeetMe · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare home based rehalitation program with real time biofeeback versus conventional physiotherapy on the gait velocity in Parkinson disease. The main question\[s\] it aims to answer are: • How do the interventions afftect the gait velocity of the participants at week 12 ? Participants will be randomized to either follow prescribtional physiotherapy or FeetMe rehabilitation programs during the first 12 weeks. At the end of 12 weeks, participants will choose in which arm they want to pursue for 12 aditionnal weeks.

Conditions

• Parkinson Disease
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
DEVICE	FeetMe rehabilitation	Home based rehabilitation program with real time biofeedback using a connected device
OTHER	Physiotherapy	Conventional physiotherapy as prescribed by the neurologists

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2023-08-18
• Last updated: 2023-08-18

Regulatory

• FDA-regulated device study