Parkinson DiseaseRe-ConnectNCT05998265
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
A study testing FeetMe rehabilitation and Physiotherapy in people with Parkinson Disease and Gait Disorders, Neurologic, run by FeetMe.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- FeetMe rehabilitation and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- FeetMe rehabilitation, Physiotherapy
- Keywords
- Rehabilitation, Remote monitoring, Physical therapy, Connected insoles
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeetMe rehabilitationDevice
Home based rehabilitation program with real time biofeedback using a connected device
PhysiotherapyOther
Conventional physiotherapy as prescribed by the neurologists
| Study group | Role | What they receive |
|---|---|---|
| FeetMe Rehabilitation arm | Experimental | Not described Receives: Device: FeetMe rehabilitation |
| Conventional physiotherapy arm | Active comparator | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT).
Measured: Week 12
Secondary outcomes (1)
Stance time variability
Change from baseline to Week 12 (Visit 3) in Stance Time Variability assessed during the 6MWT.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FeetMe
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998265
- Sponsor's protocol ID
- 2023-A00150-45
- Acronym
- Re-Connect
- Status last verified
- Jul 2023
- First submitted
- 3 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05998265
- Acronym / sponsor ID
- Re-Connect / 2023-A00150-45
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Rehabilitation, Remote monitoring, Physical therapy, Connected insoles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- FeetMeIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Lille
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FeetMe Rehabilitation arm | Experimental | Device: FeetMe rehabilitation |
| Conventional physiotherapy arm | Active comparator | Other: Physiotherapy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeetMe rehabilitationHome based rehabilitation program with real time biofeedback using a connected device | Device | FeetMe Rehabilitation arm |
| PhysiotherapyConventional physiotherapy as prescribed by the neurologists | Other | Conventional physiotherapy arm |
Primary outcome
Gait velocity
Time frame: Week 12
Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT).
1 secondary outcome
Stance time variability
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing FeetMe rehabilitation and Physiotherapy in people with Parkinson Disease and Gait Disorders, Neurologic, run by FeetMe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Moreau, MD, PhD (0320446752, caroline.moreau@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.