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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

NCT05998265 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-08-18

No results posted yet for this study

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

DEVICE

FeetMe rehabilitation

Home based rehabilitation program with real time biofeedback using a connected device

OTHER

Physiotherapy

Conventional physiotherapy as prescribed by the neurologists

Sponsors & Collaborators

  • University Hospital, Lille

    collaborator OTHER

  • FeetMe

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998265 on ClinicalTrials.gov