Digital Diagnostics and Intervention Services for Parkinson's Disease
NCT Number: NCT06534177
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Diseases|Central Nervous System Diseases|Nervous System Diseases|Joint Diseases|Musculoskeletal Diseases|Parkinson Disease|Basal Ganglia Diseases|Movement Disorders|Synucleinopathies|Neuro-Degenerative Disease|Demyelinating Disease, Autoimmune, CNS|Demyelinating Disease|Autoimmune Diseases|Immune System Diseases|Bone Diseases, Metabolic|Bone Diseases|Arthritis|Osteoporosis|Multiple Sclerosis
Sponsor: University of Exeter
Collaborators: GaitQ company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-15
Completion Date: 2026-03-01

Summary:
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

Primary Outcome Measures: 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, 2 weeks|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, 2 weeks|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, 2 weeks|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, 2 weeks|Reliability data collection for determining minimally important differnce, To determine initial values of the gaitQ of minimally important difference in relation to the TUG scores taken during the same period in the home sertting, 2 weeks|Determine intervention potential, To determine the potential for effect of the gaitQ intervention to improve key gait metrics taken during the standard tasks of TUG, 5-minute walk and 15 m walk, in order to collect clinical evidence as determined by responsiveness, of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community, 2 weeks