Development of Digital Services for Parkinson's Disease

NCT06733077 | Recruiting

• 2 other identifiers: 2023-24-1810086932
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Controls; Parkinson's Disease

Keywords

gaitQ; long-term movement condition; digital healthcare; MachineMD

Outcome Measures

Primary Outcomes (12)

• Step length

  Step length (measured in meters) during the gait tasks (TUG, 5 sit to stand, 15-m walk, 5-min walk).

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• 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).

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• 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

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• 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).

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• Timed Up and Go test

  The time (in seconds) to complete the Timed Up and Go task will be recorded.

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• Five times Sit to Stand

  The time (in seconds) a person needs to stand up from a standard height chair and sit back down five times.

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• 15-m Walk

  The time (in seconds) needed to cover 15 meters in straight line walking

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• 5-min Walk

  The distance a participant walks in 5 minutes (measured in meters and can round to the nearest decimal place).

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• Safety of the gaitQ device

  Safety of the gaitQ device will be assessed by recording the adverse events (expected and unexpected).

  From lab visit 1 to the end of the intervention (up to 6 weeks).

• Usability of the gaitQ device

  Usability of the gaitQ device will be assessed through successful establishment of a system usability scale target \>68 and through the number of therapy support sessions required.

  From lab visit 1 to the end of the intervention (up to 6 weeks).

• Ocular motor and pupil function - Standard manual test

  Ocular motor and pupil function scores derived from gaze (left, centre, right), ocular alignment, pupilary function, saccades (horizontal, vertical), smooth pursuit, visual field screening, and convergence.

  From lab visit 1 to lab visit 2 (up to 3 weeks).

• Ocular motor and pupil function - Neos device

  Ocular motor and pupil function scores derived from gaze (left, centre, right), ocular alignment, pupilary function, saccades (horizontal, vertical), smooth pursuit, visual field screening, and convergence.

  From lab visit 1 to lab visit 2 (up to 3 weeks).

Study Arms (1)

Feasibility of using the MachineMD and gaitQ devices

EXPERIMENTAL

To complete gaitQ and MachineMD digital feasibility assessment and intervention service development

Device: gait with cueing wearable device and neuro-ocular performance

Interventions

gait with cueing wearable device and neuro-ocular performance DEVICE

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.

Feasibility of using the MachineMD and gaitQ devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• University of Zurich: collaborator
• University Hospital, Zürich: collaborator
• machineMD AG: collaborator
• GaitQ company: collaborator

Study Sites (1)

University of Exeter

Exeter, EX1 2LU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Gait

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helen Dawes, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavlos Evangelidis, PhD

CONTACT

00447866138722; p.evangelidis@exeter.ac.uk

Helen Dawes, PhD

CONTACT

01392 40 2969; H.Dawes@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study (before and after)

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 13, 2024
• Study Start: December 20, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)