Parkinson's Disease and Essential Tremor
Conditions
Interventions
Medical device: Steady-Hands Software to measure hand tremorSport device: IDRO device prototype to measure sweat lactate
Sponsors
Van Broekhoven Fysiotherapie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Disturbing tremor in one or both hands in the sense of a Parkinson's disease or Essential tremor.Diagnosed with probable Parkinson's Disease and/or Essential tremor.Age at least 18 years old.Willing and able to sign an informed consent form.Willing and able to follow instructions and use mobile phone confidently.
Exclusion criteria
Exclusion criteria: Unwillingness or incapacity to take part in the study.Aged less than 18 years old.Having tattoos or scar tissue or very sensitive skin at the location where the IDRO device will be attached (subscapular left)Inability to perform a cardiovascular incremental exercise test on a stationary bike
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hand tremor intensity assessment (symptom quantification using the stability score) endpoint is agreement between the scores obtained using Steady Hands and those from the conventional tremor rating scales. Performance of Steady Hands in distinguishing between PD and ET, measured against confirmed clinical diagnoses. | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify and characterize associations between sweat lactate values and thresholds measured using the IDRO device and symptoms in PD and ET (not as a medical device).To identify and characterize association between the evolution of sweat lactate values and thresholds over time and the evolution of symptoms in PD and ET over time (not as a medical device).The other secondary outcomes are designed to capture Steady Hands safety, usability, and data quality for future algorithm refinement, evaluated through:Safety Metrics:Adverse Event Rate: Documented as events per 100 device uses, including stratified analysis by home vs. clinical settings.Severity and Causality Analysis: Categorization of adverse events by severity (mild, moderate, severe) and their causality (related, unrelated, or possibly related to device use).Algorithm Optimization Indicators:Data quality and completeness metrics:Proportion of Usable Data: Percentage of collected data that meets quality criteria for algorithm development. | — |
Countries
Greece, Netherlands
Contacts
Public ContactSophie Vervullens
IDRO B.V.
Outcome results
None listed