Mobilise-D: Extension Study

NCT05874739 | Recruiting

• 4 other identifiers: 10402MJFF-022735MJFF-022736323855
• Study Type: observational
• Target: 651
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Aging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Difference in Real Walking Speed

  36 months (PD) and 12 months (control)

• Fall frequency in controls

  12 months

• Ability of Real Walking Speed to detect change in PD severity

  36 months

• Ability of Real Walking Speed to predict change in physical capacity

  36 months (PD) and 12 months (control)

• Ability of Real Walking Speed to predict change in PD severity

  36 months

Study Arms (2)

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

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

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• KU Leuven: collaborator
• University of Kiel: collaborator
• University Hospital Erlangen: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• University College Dublin: collaborator

Study Sites (1)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alison Yarnall, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel K Neatrour, MSc

CONTACT

+44 (0) 191 2081406; isabel.neatrour@newcastle.ac.uk

Alison Yarnall, PhD

CONTACT

+44 (0)191 2081279; alison.yarnall@newcastle.ac.uk

Study Design

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

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 25, 2023
• Study Start: May 17, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years
• 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)

Locations

GB (1)