An interventional study of The FeetMe® Evaluation and the PKG® Watch, in Parkinson Disease, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Prevention
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:
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 83 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
PD Patients:
Each group will be composed of:
Healthy subjects
For all
Exclusion Criteria:
Device: The FeetMe® Evaluation · Device: the PKG® Watch, · Radiation: MRI · Radiation: DaTSCAN
Device: The FeetMe® Evaluation · Radiation: MRI
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® 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,
* an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic): * anatomical registration * automated segmentation * volumetric * texture analysis
* quantify nigrostriatal dopaminergic depletion * correlate its impact on the type and severity of gait disorders in Parkinson's disease.
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
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
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
For MSA subgroup and all subgroups
Time frame: at baseline at 24 and 48 weeks
DAT-scan changes at 48 weeks versus baseline.
For Early PD subgroup
Time frame: at baseline at 48 weeks
PKG changes at 48 weeks versus baseline
in early PD and fluctuating subgroups.
Time frame: at baseline and at 48 weeks
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille