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 (Re-Connect)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Gait Disorders, Neurologic
• Intervention / Treatment: Device: FeetMe rehabilitation; Other: Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Moreau, MD, PhD; Phone Number: 0320446752; Email: caroline.moreau@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent to participate in the study.
• Male or female patients between 40 to 70 years of age, inclusive.
• Body weight range of 40 kg to120 kg and a body mass index (BMI) of 18 to 34 kg/m2.
• Diagnosis of Idiopathic Parkinson's disease (PD) according to UK Brain Bank Criteria (2/3 symptoms), with Hoehn and Yahr (H&Y) staging level 2, 2.5 or 3.
• Disease onset of at least 3 years prior to enrolment.
• Patients with a history of 50% of levodopa responsiveness based on motor signs.
• On stable treatment of PD medication for at least 30 days before screening and with no expected major changes during the first 3 months of the study.
• Prescription for physiotherapy available.
• Ability to walk without aid for at least 6 minutes.
• Shoe size between 35 - 46 (European Standard).
• Intact skin on feet.
• Adequate visual and auditory acuity to perform the rehabilitation program and the assessments in the Investigator's judgement.
• Comfortable with the use of a smartphone. If assistance is required for the use of FeetMe technology, a caregiver or volunteer is fully available to assist the patient.
• Willingness to be regularly contacted via phone-calls.
• Willingness to suspend conventional physiotherapy treatment and start the FeetMe rehabilitation program, if applicable.
• French speaker.

Exclusion Criteria:

• Medical history indicating a Parkinsonian syndrome other than idiopathic PD.
• Unable to walk without walking aid or presence of an injury preventing the patient to walk.
• Any relevant comorbidity or vestibular/visual dysfunctions limiting locomotion or balance.
• Clinically significant comorbidities which in the judgement of the investigator may preclude the reliable gait assessment of the patient.
• Patients with poor wound healing or broken skin on the feet.
• Patients with foot implants.
• Montreal Cognitive Assessment (MoCA) score ≤ 24/30.
• Patients with dementia.
• Patients with apathy.
• Participation in another clinical trial with an investigational drug/ therapeutic within the three months before screening and during the study, unless agreed by the Sponsor.
• Patients who had Lee Silverman Voice Treatment (LSVT) Big therapy within the past 12 months or have it planned during the course of the study.
• Patients with Deep Brain Stimulation planned during the first 12 weeks of the study.
• Patients with pacemakers.
• Patients performing vigorous exercise > three times a week, 30 mins or more per session.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FeetMe Rehabilitation arm	Device: FeetMe rehabilitation; Home based rehabilitation program with real time biofeedback using a connected device
Active Comparator: Conventional physiotherapy arm	Other: Physiotherapy; Conventional physiotherapy as prescribed by the neurologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait velocity	Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stance time variability	Change from baseline to Week 12 (Visit 3) in Stance Time Variability assessed during the 6MWT.	Week 12

Collaborators and Investigators

• Sponsor: FeetMe
• Collaborators: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy; Remote monitoring; Connected insoles
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 2023-A00150-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No