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

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

Plain Language Summary

Simplified for easier understanding

This study is developing and testing digital tools (such as smartphone apps and wearable sensors) to help people with Parkinson's disease manage gait freezing — a sudden, brief inability to walk — and other movement challenges in their daily lives. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of idiopathic Parkinson's disease (or another specified condition like stroke, multiple sclerosis, arthritis, or osteoporosis) - You regularly experience freezing of gait or difficulty with walking and movement - You can walk for at least 5 minutes (with or without an aid) - Your vision is normal or corrected to near-normal - Your cognitive function is adequate to follow 2-step instructions **You may NOT be eligible if...** - You have severe cognitive impairment - You have significant uncorrected vision problems - You are medically unable to engage in the required level of physical activity Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of Exeter

Exeter, United Kingdom

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NCT06733077


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