RecruitingNot ApplicableNCT06733077

Development of Digital Services for Parkinson's Disease

Development of Digital Diagnostics and Intervention Services for Parkinson's Disease

Sponsor

University of Exeter

Enrollment

80 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson's Disease Healthy (Controls)

Summary

In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD. With this, the investigators aim to advance the state of the art in PD diagnosis and monitoring. By integrating the principles of machine learning with high-quality sensor data, more accurate and earlier diagnosis could potentially be achieved. Ocular motor and pupil data will be collected with the standard clinical examination and with neos, a medical device approved for objective ocular motor and pupil measurement. Gait will be collected using an IMU sensor and GaitQ senti, a consumer device that allows for an objective and continuous remote gait monitoring.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \[stroke, multiple sclerosis, arthritis or osteoporosis\]
Able to self-report history of daily gait freezing and/or festination for people with PD or gait and/or transfers affected by condition
Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise
Adult (+18 years old)
Normal or corrected-to-normal vision (Snellen Visual Acuity \> 12/18) or safe to mobilise with support
Montreal Cognitive assessment score \>21 or ability to follow 2 stage commands
Healthy participants \[Phase 1,2,3\]
With no long-term conditions affecting movement
Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise
Adult (+18 years old)
Normal or corrected-to-normal vision (Snellen Visual Acuity \> 12/18) or safe to mobilise with support
Montreal Cognitive assessment score \>21 or ability to follow 2 stage commands

Exclusion Criteria12

Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.
Cognitive impairment affecting ability to safely participate and follow instructions
Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)
Any skin conditions or broken skin in the calf and behind knee area
Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system
Medications likely to affect eye sight or use of virtual reality sytstem
Healthy participants
Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.
Cognitive impairment affecting ability to safely participate and follow instructions
Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)
Any skin conditions or broken skin in the calf and behind knee area
Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system

Interventions

DEVICEgait with cueing wearable device and neuro-ocular performance

Participants will be invited to participate in the following sequential phases. Participants can participate in Phases as selected. Control participants will not be invited to Phase 4. Phase 1. Lab testing \[2 hours\] Validation study of digital technology measures MachineMD and gaitQ to criterion metric of UPDRS. Phase 2. home/community testing \[2 weeks daily\] Determine feasibility of daily measuring in the home of gaitQ to determine usability, acceptability, and day to day variability of measurement metrics and to determine concurrent validation of home metric to lab metrics to determine, reliability, concurrent validity of change, minimal detectable change and criterion validation to lab-based measures. Phase 3. Lab retesting \[2 hours\] see Phase 1 Phase 4. Home/community intervention \[2 weeks\] Determine the potential for effect of the gaitQ vibration intervention from a 2-week exposure in the home.