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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 | Clinical Trials | Clareo Health

UNKNOWNNA

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•FeetMe

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

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).
+6 more criteria

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.
+4 more criteria

Key Dates

Start Date

November 1, 2023

Primary Completion Date

November 1, 2025

Completion Date

November 1, 2025

Last Updated

August 18, 2023

Enrollment

150

ESTIMATED participants

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Interventions

FeetMe rehabilitation

DEVICE

Physiotherapy

OTHER

Contacts

Caroline Moreau, MD, PhD

CONTACT

0320446752 caroline.moreau@chru-lille.fr

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Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

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