Digital Diagnostics and Intervention Services for Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Exeter

About this trial

People with Parkinson's have infrequent clinical consultation (once every 12-18 months) and limited rehabilitation.

Assessment play an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes. There is a strong need for more frequent and accurate Parkinson's assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly. There is a need to develop good home digital physiotherapy tools to increase the amount of therapy. Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home. The investigators aim to conduct a clinical study with 50 people with Parkinson's (50 from UK) with the UPDRS, (a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinson's disease) and 30 healthy adults. The investigators will develop and investigate if two new digital devices, one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS (motor) using digital gait and ophthalmic features in the clinic setting. The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home. The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Participants with long-term conditions affecting movement

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

Trial population

Recruiting adult males and females, both healthy and those with neurodegenerative disease ie. Parkinson's disease

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Participants with long-term conditions affecting movement
Group B: Healthy control

Trial outcomes

Primary outcomes

1

Lab validation of MachineMD opthalamic device vs UPDRS

To determine criterion validity to the UPDRS by describing the extent of the relationship of the digital measures taken during mobility testing and neuro-Opthalmic testing in the lab/clinic to the UPDRS

Time frame
2 weeks
2

Reliability testing of GaitQ wearable device

To determine the extent of the reliability of the digital measures in the context of test-retest reliability taken over 2 weeks in a lab/clinic setting

Time frame
2 weeks
3

Home/community validation

To determine day to day gaitQ metrics taken during standard testing tasks of TUG, 15 m walk and 5-minute walk in the home/community setting to establish criterion validity to the lab measures and the day-to-day variability of the gaitq tempo measures to determine minimal detectable change

Time frame
2 weeks
4

Home/community validation

To describe the feasibility of daily measuring in the home of gaitQ tempo to determine usability and acceptability from metrics and completion of measures

Time frame
2 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Exeter

Lead sponsor

GaitQ company

Collaborator

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