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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 (Re-Connect)

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FeetMe rehabilitation
Physiotherapy
Sponsored by
FeetMe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Rehabilitation, Remote monitoring, Physical therapy, Connected insoles

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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). 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FeetMe Rehabilitation arm

    Conventional physiotherapy arm

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 3, 2023
    Last Updated
    August 16, 2023
    Sponsor
    FeetMe
    Collaborators
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05998265
    Brief Title
    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
    Acronym
    Re-Connect
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    FeetMe
    Collaborators
    University Hospital, Lille

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Gait Disorders, Neurologic
    Keywords
    Rehabilitation, Remote monitoring, Physical therapy, Connected insoles

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FeetMe Rehabilitation arm
    Arm Type
    Experimental
    Arm Title
    Conventional physiotherapy arm
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    FeetMe rehabilitation
    Intervention Description
    Home based rehabilitation program with real time biofeedback using a connected device
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy
    Intervention Description
    Conventional physiotherapy as prescribed by the neurologists
    Primary Outcome Measure Information:
    Title
    Gait velocity
    Description
    Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT).
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Stance time variability
    Description
    Change from baseline to Week 12 (Visit 3) in Stance Time Variability assessed during the 6MWT.
    Time Frame
    Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caroline Moreau, MD, PhD
    Phone
    0320446752
    Email
    caroline.moreau@chru-lille.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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