Development of Digital Services for Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Exeter
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
gait with cueing wearable device and neuro-ocular performance
DeviceParticipants 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Feasibility of using the MachineMD and gaitQ devicesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Step length
Step length (measured in meters) during the gait tasks (TUG, 5 sit to stand, 15-m walk, 5-min walk).
Time frame
From lab visit 1 to lab visit 2 (up to 3 weeks).2
Step rate
Step rate (measured in steps per minute) will be measured during the gait tasks (TUG, 5 sit to stand, 15-m walk, 5-min walk).
Time frame
From lab visit 1 to lab visit 2 (up to 3 weeks).3
Step length symmetry index
Step length symmetry index will be calculated using the following equation: \[((R - L)/0.5 × (R + L)) × 100\], where R: right leg, L: left leg
Time frame
From lab visit 1 to lab visit 2 (up to 3 weeks).4
Walking speed
Walking speed (meters per second) will be measured during the gait activities (TUG, 5 sit to stand, 15-m walk, 5-min walk).
Time frame
From lab visit 1 to lab visit 2 (up to 3 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Exeter
Lead sponsor
University of Zurich
Collaborator
University Hospital, Zürich
Collaborator
machineMD AG
Collaborator
GaitQ company
Collaborator
Source ClinicalTrials.gov