Mobilise-D: Extension Study

Validating a Digital Mobility Assessment in Parkinson's Disease Using Wearable Technology - the Mobilise-D Extension Study.

The goal of this observational study is to investigate the ability of a mobility monitor to measure and predict outcomes in Parkinson's disease (PD). It is an extension of a previous study (the Mobilise-D Clinical Validation Study) and consists of an additional follow-up visit for PD participants and the recruitment of age matched control participants. The data will inform researchers about PD disease progression and normal changes in mobility associated with aging.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Aging

Detailed Description

This study is an extension to the Mobilise-D project which aims to develop a real world digital assessment of mobility. This Extension Study will build on the work of the Clinical Validation Study (CVS) to extend the follow-up period of the Parkinson's disease (PD) cohort and to recruit an age matched control cohort. The additional data will for allow for modelling of disease progression in PD over a longer time period and inform on progression in normal ageing.

The Mobilise-D Extension Study is an observational cohort study taking place at five clinical sites across four different countries. The study will recruit up to 551 PD participants from the CVS PD cohort and 200 age and gender matched control participants.

The PD participants will attend a single follow-up visit 36 months after their initial CVS baseline visit. The control participants will attend a baseline visit and a 12-month follow-up visit. All study visits consist of the collection of descriptive, clinical, physical, neuropsychological data. Following each visit, participants are required to wear a body worn sensor for seven days continual monitoring.

A small sample of participants will be invited to take part in a semi-structured interview (Qualitative Sub Study) to better understand participants' experiences of PD symptoms and the impact they have on mobility. The investigators also want to know if the aspects of mobility that are being measured are relevant to people with PD. These interviews will take place face to face or remotely, depending on preference.

• Study Type: Observational
• Enrollment (Estimated): 751

Contacts and Locations

• Study Contact: Name: Isabel K Neatrour, MSc; Phone Number: +44 (0) 191 2081406; Email: isabel.neatrour@newcastle.ac.uk
• Study Contact Backup: Name: Alison Yarnall, PhD; Phone Number: +44 (0)191 2081279; Email: alison.yarnall@newcastle.ac.uk

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom
    • Recruiting
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    • Contact: Philip Brown
    • Principal Investigator: Alison Yarnall, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Control cohort participants will be identified through Public and Patient Networks and Engagement teams and banks of volunteers already known to clinical sites. Control individuals may also be relatives or friends of PD participants. PD cohort participants will be recruited from the Mobilise-D Clinical Validation Study.

Description

Control Cohort:

Inclusion Criteria:

• Aged 50 years or over
• Able to walk 4 meters independently without walking aids
• Anticipated availability for 12 months.
• Ability to consent and comply with any study specific procedures.
• Willingness to wear a wearable sensor for mobility monitoring
• Able to read and write in first language in the respective country

Exclusion Criteria:

• Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological or orthopaedic impairment that significantly impacts on gait
• Patients with a clinical diagnosis of PD, COPD, proximal hip fracture or MS
• History of dementia/significant cognitive impairment, or movement disorder (including essential tremor)

PD Cohort

Inclusion Criteria:

• Participant in the Mobilise-D Clinical Validation Study (CVS) PD Cohort - see below.

CVS PD Cohort:

Inclusion criteria:

• Aged 18 or over
• Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society
• Hoehn & Yahr stage I-III

Exclusion Criteria:

• History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria)
• Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of 'vascular parkinsonism'
• Drug-induced Parkinsonism

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control Cohort; Control participants who are age- and gender-matched to the PD cohort
PD Cohort; PD Patients who have completed their participation in the Mobilise-D Clinical Validation Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LLFDI in controls	Change in the functional component score of the Late-Life Functional Disability Index (LLFDI) in control data. This assessment has 32 items, each with a scale from 5 (no difficulty) to 1 (unable to do). Raw scores are transformed into summary scores ranging from 0 (low level in ability) to 100 (high level of ability).	12 months
Change in LLFDI in PD	Change in the functional component score of the Late-Life Functional Disability Index (LLFDI) in PD data. This assessment has 32 items, each with a scale from 5 (no difficulty) to 1 (unable to do). Raw scores are transformed into summary scores ranging from 0 (low level in ability) to 100 (high level of ability).	36 months
Change in fall frequency in PD	Change in fall frequency (in previous 6 months) in PD data	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Real Walking Speed	Assess difference in Real Walking Speed between PD and control data as measured using a body worn sensor during a 7-day digital mobility assessment (DMA)	36 months (PD) and 12 months (control)
Fall frequency in controls	Change in fall frequency (in previous 6 months) in control data	12 months
Ability of Real Walking Speed to detect change in PD severity	Ability of Real Walking Speed (measured through digital mobility assessment) to detect change in PD disease severity as measured by the MDS Unified Parkinson's Disease Rating Scale (UPDRS). This assessment has 32 items, each with a scale from 5 (no difficulty) to 1 (unable to do). Raw scores are transformed into summary scores ranging from 0 (low level in ability) to 100 (high level of ability).	36 months
Ability of Real Walking Speed to predict change in physical capacity	Ability of Real Walking Speed (measured through digital mobility assessment) to detect change in physical capacity in PD and control data, as measured through the Late-Life Functional Disability Index (LLFDI). This assessment has 32 items, each with a scale from 5 (no difficulty) to 1 (unable to do). Raw scores are transformed into summary scores ranging from 0 (low level in ability) to 100 (high level of ability).	36 months (PD) and 12 months (control)
Ability of Real Walking Speed to predict change in PD severity	Ability of Real Walking Speed (measured through digital mobility assessment) to predict change in PD disease severity as measured by the MDS Unified Parkinson's Disease Rating Scale (UPDRS). This assessment has 32 items, each with a scale from 5 (no difficulty) to 1 (unable to do). Raw scores are transformed into summary scores ranging from 0 (low level in ability) to 100 (high level of ability).	36 months

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: KU Leuven; University College Dublin; University of Kiel; Tel-Aviv Sourasky Medical Center; University Hospital Erlangen
• Investigators: Principal Investigator: Alison Yarnall, PhD, Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): July 28, 2025
• Study Completion (Estimated): July 28, 2025

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 10402 (Other Identifier: CTEP); MJFF-022735 (Other Grant/Funding Number: The Michael J. Fox Foundation for Parkinson's Research.); MJFF-022736 (Other Grant/Funding Number: The Michael J. Fox Foundation for Parkinson's Research.); 323855 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full anonymised dataset will be made available on the Mobilise-D platform
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: The dataset will be made available to the wider research community for secondary research purposes. Data may also be shared with The Michael J. Fox Foundation for Parkinson's Research (the study funder)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No