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NCT06534177

Digital Diagnostics and Intervention Services for Parkinson's Disease

Sponsor: University of Exeter

View on ClinicalTrials.gov

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

Official title: Development of Digital Diagnostics and Intervention Services for Parkinson's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2024-10-15

Completion Date

2026-03-01

Last Updated

2024-08-09

Healthy Volunteers

Yes

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 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

Clinical Research Directory

Digital Diagnostics and Intervention Services for Parkinson's Disease

Summary

Key Details

Conditions

Eligibility Criteria