Mobilise-D: Extension Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNewcastle-upon-Tyne Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Participant in the Mobilise-D Clinical Validation Study (CVS) PD Cohort - see below.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
651 Participants
are grouped into 2 trial groupsGroup A: Control Cohort
Group B: PD Cohort
Trial outcomes
Primary outcomes
1
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).
Time frame
12 months2
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).
Time frame
36 months3
Change in fall frequency in PD
Change in fall frequency (in previous 6 months) in PD data
Time frame
36 monthsSecondary outcomes
1
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)
Time frame
36 months (PD) and 12 months (control)2
Fall frequency in controls
Change in fall frequency (in previous 6 months) in control data
Time frame
12 months3
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).
Time frame
36 months4
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).
Time frame
36 months (PD) and 12 months (control)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Newcastle-upon-Tyne Hospitals NHS Trust
Lead sponsor
KU Leuven
Collaborator
University of Kiel
Collaborator
University Hospital Erlangen
Collaborator
Tel-Aviv Sourasky Medical Center
Collaborator
University College Dublin
Collaborator
Source ClinicalTrials.gov