This prospective observational study will examine tremor and upper-limb movement in adults with Parkinson's disease or essential tremor using non-invasive wearable sensors. Participants will attend one clinic visit and may then wear sensors at home for 3, 7, or 21 days. Clinic assessments will be scheduled around participants' usual medication times; the study will not change or delay treatment. Sensor data will be analysed offline for research and will not be used to make clinical decisions.
Aged 18 years or older.
Clinical diagnosis of idiopathic Parkinson's disease (Hoehn and Yahr stage I-III) or essential tremor.
Motor or tremor symptoms confirmed on clinical assessment.
Able to walk at least 4 metres independently, with or without a walking aid.
A recent major cardiovascular or cerebrovascular event, or another unstable condition that would make participation unsafe.
An uncontrolled psychiatric disorder, ongoing substance misuse, active systemic cancer treatment, or another serious illness likely to interfere with participation.
Pregnancy at enrolment.
Active skin disease or known allergy to adhesive plaster at anticipated sensor sites.
Adults with a clinical diagnosis of idiopathic Parkinson's disease or essential tremor receiving care through NHS Lothian services. Potential participants will be identified through relevant NHS clinical pathways.
Cohort
Prospective
Device exposure: Wearable inertial sensor monitoring
DevicePD-WATCH and comparator wearable sensors are used only to collect research data. Both cohorts continue their usual medication and clinical care; no treatment is assigned or changed by the study.
Wearable sensor data completeness for tremor and upper-limb movement analysis
Percentage of participants with sufficient valid wearable sensor data to extract predefined tremor and upper-limb movement features for descriptive analysis. This will be calculated as the number of participants with usable sensor recordings divided by the number of participants who started the relevant clinic or home-monitoring assessment, multiplied by 100.
Completeness of paired wearable and clinical assessment data
Percentage of participants with usable paired wearable sensor recordings and clinician-rated motor assessment data available for exploratory correlation analysis. This will be calculated as the number of participants with both valid wearable data and relevant clinical assessment data divided by the number of participants completing the clinic visit, multiplied by 100.
Participant-rated device comfort and usability score
Mean participant-rated device comfort and usability score, calculated from study questionnaire items scored from 1 to 5. A score of 1 indicates "not satisfied" and 5 indicates "very satisfied". Higher scores indicate better comfort, usability, perceived safety, and acceptability. Scores will be reported separately for Day 1 and for completion of home monitoring, where available.
Completeness of paired home wearable and diary data
Percentage of participants with sufficient paired home wearable sensor data and participant diary data available for time-aligned descriptive analysis. This will be calculated as the number of participants with usable wearable recordings and corresponding medication, symptom, or activity diary entries divided by the number of participants who started home monitoring, multiplied by 100.
Completeness of paired pre-dose and post-dose wearable data
Percentage of participants with usable wearable sensor recordings at both pre-dose and post-dose clinic assessments available for within-participant descriptive comparison. This will be calculated as the number of participants with valid wearable data at both clinic timepoints divided by the number of participants completing both clinic assessments, multiplied by 100.
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Heriot-Watt University
Lead sponsor
NHS Lothian
Collaborator
