Parkinson DiseaseGait'N'ParkNCT04653688
Markers of Disease Progression and Gait Within the Parkinsonian Population
A study testing The FeetMe® Evaluation, the PKG® Watch, and MRI in people with Parkinson Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis. We identified several steps in this project: 1. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- The FeetMe® Evaluation, the PKG® Watch, and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2020to 17 Oct 2024
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PD Patients:
- Age: from 40 to 80 years
- Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)
- Each group will be composed of:
- 30 PD with a disease duration < 3 years
- 30 PD with a disease duration between 5 to 8 years
Show all 19Show fewer
- 30 PD with a disease duration > 10 years MSA Patients
- Age > 30 years old
- < 5 years of disease duration
- deemed by the physicians to be able to walk at 1 year
- Healthy subjects
- Similar age and sex distribution
- For all
- Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)
- Absence of cognitive disorders (MoCA> 24/30 according to the MDS criteria)
- Stable treatment for at least 2 weeks before inclusion
- Ability to walk at least 100 meters
- Have an affiliation to the social security or equivalent
- Have signed an informed consent
Who cannot join
- STN DBS for PD patients
- Intraduodeno-jejunal levodopa infusion (duodopa)
- Inability to walk without aid (walker or walking stick)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population
The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.
We identified several steps in this project:
- Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:
- 30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018)
- 30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018)
- 30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018)
- 30 patients with MSA (less than 5 years after the first symptom)
- Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT …) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.
- Conditions
- Parkinson Disease
- Being tested
- The FeetMe® Evaluation, the PKG® Watch,, MRI, DaTSCAN
- Keywords
- Gait disorders, On-OFF detection, FOG detection, Quality of life, personalize medicine, telemedicine
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The FeetMe® EvaluationDevice
The FeetMe® Evaluation device is a medical device (class Im CE 0459) for ambulatory gait analysis, consisting of a pair of connected insoles and an Android mobile application.
the PKG® Watch,Device
The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® system consists of a wrist-worn movement recording device known as the PKG® Watch,
MRIRadiation
- an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic):
- anatomical registration
- automated segmentation
- volumetric
- texture analysis
DaTSCANRadiation
- quantify nigrostriatal dopaminergic depletion
- correlate its impact on the type and severity of gait disorders in Parkinson's disease.
| Study group | Role | What they receive |
|---|---|---|
| Parkinsonian syndromes patients | Experimental | Not described Receives: Device: The FeetMe® Evaluation; Device: the PKG® Watch,; Radiation: MRI; Radiation: DaTSCAN |
| healthy subjects | Sham comparator | Not described Receives: Device: The FeetMe® Evaluation; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group.
Measured: at 48 weeks
Secondary outcomes (14)
Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only) and 24 weeks versus baseline in Parkinsonian syndrome patient subgroups
Measured: at baseline at 12weeks, at 24 weeks and 48 weeks
Changes of 95th percentile of home gait cadence, stride length, stride, stance and swing durations (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only), 24 and 48 weeks versus baseline
Measured: at baseline at 12weeks, at 24 weeks and 48 weeks
Changes of UMSARS I-II versus baseline in MSA subgroup
UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.
Measured: at baseline at 12weeks, at 24 weeks and 48 weeks
Changes of MSA-QoL versus baseline in MSA subgroup
MSA-QoL is a patient-rated health-related Quality of life scale for patients with multiple system atrophy (MSA). Visual Analog score is designed to determine overall life satisfaction in patient with MSA. Scale is given response option format (0 - extremely unsatisfied with life 100 - extremely satisfied with life), where higher scores indicate better satisfaction/quality of life.
Measured: at baseline at 24 and 48 weeks
Changes of OHQ versus baseline in MSA subgroup
OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness
Measured: at baseline at 24 and 48 weeks
Changes of OHSA versus baseline in MSA subgroup
Orthostatic Hypotension Symptom Assessment (OHSA) and Orthostatic Hypotension Daily Activities Scale (OHDAS) 10 items measured on a Likert-scale
Measured: at baseline at 24 and 48 weeks
Changes of BBS versus baseline in MSA subgroup
Berg Balance Scale (BBS) is a clinical 14-item scale designed to measure balance
Measured: at baseline at 24 and 48 weeks
Changes of Modified SE-ADL versus baseline in MSA subgroup
The Schwab and England Activities of Daily Living (SE-ADL) evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. The assessment is conducted by a trained clinician.
Measured: at baseline at 24 and 48 weeks
Changes of PDSS-2 versus baseline in MSA subgroup
The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
Measured: at baseline at 24 and 48 weeks
Changes of COMPASS31 versus baseline in MSA subgroup
Composite Autonomic Symptom Score (CONPASS 31) includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present
Measured: at baseline at 24 and 48 weeks
Changes of MOCA versus baseline in MSA subgroup
Measured: at baseline at 24 and 48 weeks
MRI changes at 24 and 48 weeks versus baseline.
For MSA subgroup and all subgroups
Measured: at baseline at 24 and 48 weeks
DAT-scan changes at 48 weeks versus baseline.
For Early PD subgroup
Measured: at baseline at 48 weeks
PKG changes at 48 weeks versus baseline
in early PD and fluctuating subgroups.
Measured: at baseline and at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start22 Dec 2020
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
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.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S, France Parkinson Association, Vaincre Parkinson, FeetMe
- Responsible party
- Sponsor
- Investigators
- Caroline Moreau, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653688
- Sponsor's protocol ID
- 2019_64
- Other IDs
- 2020-A01998-31
- Acronym
- Gait'N'Park
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population
- ClinicalTrials.gov ID
- NCT04653688
- Acronym / sponsor ID
- Gait'N'Park / 2019_64
- Conditions
- Parkinson Disease
- Keywords
- Gait disorders, On-OFF detection, FOG detection, Quality of life, personalize medicine, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S, France Parkinson Association, Vaincre Parkinson, FeetMe
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 4 Dec 2020 (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 aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.
We identified several steps in this project:
- Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:
- 30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018)
- 30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018)
- 30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018)
- 30 patients with MSA (less than 5 years after the first symptom)
- Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT …) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinsonian syndromes patients | Experimental | Device: The FeetMe® Evaluation, Device: the PKG® Watch,, Radiation: MRI, Radiation: DaTSCAN |
| healthy subjects | Sham comparator | Device: The FeetMe® Evaluation, Radiation: MRI |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age: from 40 to 80 years
- Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)
- 30 PD with a disease duration < 3 years
- 30 PD with a disease duration between 5 to 8 years
- 30 PD with a disease duration > 10 years MSA Patients
Key exclusion criteria (3 listed)
- STN DBS for PD patients
- Intraduodeno-jejunal levodopa infusion (duodopa)
- Inability to walk without aid (walker or walking stick)
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 |
|---|---|---|
| The FeetMe® EvaluationThe FeetMe® Evaluation device is a medical device (class Im CE 0459) for ambulatory gait analysis, consisting of a pair of connected insoles and an Android mobile application. | Device | Parkinsonian syndromes patients, healthy subjects |
| the PKG® Watch,The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® system consists of a wrist-worn movement recording device known as the PKG® Watch, | Device | Parkinsonian syndromes patients |
| MRI* an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic): * anatomical registration * automated segmentation * volumetric * texture analysis | Radiation | Parkinsonian syndromes patients, healthy subjects |
| DaTSCAN* quantify nigrostriatal dopaminergic depletion * correlate its impact on the type and severity of gait disorders in Parkinson's disease. | Radiation | Parkinsonian syndromes patients |
Primary outcome
Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group.
Time frame: at 48 weeks
14 secondary outcomes
Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only) and 24 weeks versus baseline in Parkinsonian syndrome patient subgroups
Time frame: at baseline at 12weeks, at 24 weeks and 48 weeks
Changes of 95th percentile of home gait cadence, stride length, stride, stance and swing durations (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only), 24 and 48 weeks versus baseline
Time frame: at baseline at 12weeks, at 24 weeks and 48 weeks
Changes of UMSARS I-II versus baseline in MSA subgroup
Time frame: at baseline at 12weeks, at 24 weeks and 48 weeks
Changes of MSA-QoL versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of OHQ versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of OHSA versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of BBS versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of Modified SE-ADL versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of PDSS-2 versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of COMPASS31 versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
Changes of MOCA versus baseline in MSA subgroup
Time frame: at baseline at 24 and 48 weeks
MRI changes at 24 and 48 weeks versus baseline.
Time frame: at baseline at 24 and 48 weeks
DAT-scan changes at 48 weeks versus baseline.
Time frame: at baseline at 48 weeks
PKG changes at 48 weeks versus baseline
Time frame: at baseline and at 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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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.
Caroline Moreau, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The FeetMe® Evaluation, the PKG® Watch, and MRI in people with Parkinson Disease, run by University Hospital, Lille at 1 site in France.
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 19 inclusion and 3 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group. (time frame: at 48 weeks). 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 4 Dec 2025.