PARKINSON DISEASE (Disorder)
Conditions
Keywords
Tremor, Upper-limb movement, Home monitoring, Inertial measurement unit, Wearable sensors
Brief summary
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.
Detailed description
The study will recruit up to 60 adults through NHS Lothian: 40 with Parkinson's disease and 20 with essential tremor. During the clinic visit, participants will complete clinical assessments and movement tasks while wearing the PD-WATCH research sensor and comparator wearable sensors. Participants allocated to home monitoring will wear the sensors during usual daily activities and complete brief medication, symptom, and activity logs. The study will describe wearable-derived movement features, explore their relationships with clinical assessments and medication timing, and assess the feasibility and acceptability of wearable monitoring. The study is exploratory and is not designed to evaluate diagnostic accuracy, treatment effects, or device performance.
Interventions
DEVICEDevice exposure: Wearable inertial sensor monitoring
PD-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.
Sponsors
Heriot-Watt University
NHS Lothian
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older. 2. Clinical diagnosis of idiopathic Parkinson's disease (Hoehn and Yahr stage I-III) or essential tremor. 3. Motor or tremor symptoms confirmed on clinical assessment. 4. Able to walk at least 4 metres independently, with or without a walking aid. 5. Able to provide written informed consent and comply with study procedures. 6. Willing and able to wear the study sensors in clinic and, where applicable, at home. 7. Able to understand study information and complete study materials in English.
Exclusion criteria
1. A recent major cardiovascular or cerebrovascular event, or another unstable condition that would make participation unsafe. 2. An uncontrolled psychiatric disorder, ongoing substance misuse, active systemic cancer treatment, or another serious illness likely to interfere with participation. 3. Pregnancy at enrolment. 4. Active skin disease or known allergy to adhesive plaster at anticipated sensor sites. 5. Dementia with Lewy Bodies, atypical, vascular, or drug-induced parkinsonism. 6. Previous invasive neuromodulation or neurosurgery for a movement disorder, including deep brain stimulation. 7. Current or recent participation in another interventional study that could affect safety or study outcomes. 8. In the investigator's opinion, unable to complete the study procedures safely.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearable sensor data completeness for tremor and upper-limb movement analysis | Day 1 through completion of home monitoring, up to 22 days. | 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 | Day 1. | 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 | Day 1 and at completion of home monitoring, up to 22 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of paired home wearable and diary data | Home monitoring period, up to 21 days. | 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 | Day 1. | 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. |
Countries
United Kingdom
Contacts
CONTACTGordon Duncan
CONTACTAnne Bernassau
STUDY_CHAIRAnne Bernassau
Heriot-Watt University
PRINCIPAL_INVESTIGATORGordon Duncan
NHS Lothian
Outcome results
None listed