Digital Diagnostics and Intervention Services for Parkinson's Disease

NCT06534177 | Not Yet Recruiting DMC

• 1 other identifier: 340549
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

parkinson's disease; osteoarthritis; stroke; MS; osteoporosis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Participants with long-term conditions affecting movement

A total number of 50 people with long-term conditions affecting their movement include people with Parkinson's

Healthy control

A total number of 30 healthy people with no condition impacting their movement and walking ability.

Eligibility Criteria

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

Study Population

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

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:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• GaitQ company: collaborator

MeSH Terms

Conditions

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Parkinson Disease; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Arthritis; Osteoporosis; Multiple Sclerosis; Osteoarthritis; Stroke

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases of the Nervous System; Leukoencephalopathies; Rheumatic Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: October 15, 2024
• Primary Completion: July 31, 2025
• Study Completion: March 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08