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 | Unknown FDA Device

• 1 other identifier: 2023-A00150-45
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Rehabilitation; Remote monitoring; Physical therapy; Connected insoles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stance time variability

  Week 12

Study Arms (2)

FeetMe Rehabilitation arm

EXPERIMENTAL

Device: FeetMe rehabilitation

Conventional physiotherapy arm

ACTIVE COMPARATOR

Other: Physiotherapy

Interventions

FeetMe rehabilitation DEVICE

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

FeetMe Rehabilitation arm

Physiotherapy OTHER

Conventional physiotherapy as prescribed by the neurologists

Conventional physiotherapy arm

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FeetMe: lead
• University Hospital, Lille: collaborator

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Caroline Moreau, MD, PhD

CONTACT

0320446752; caroline.moreau@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 18, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share