Parkinson DiseaseNCT05874739
Mobilise-D: Extension Study
An observational study of Parkinson Disease and Aging, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Aging
- How many people
- 651 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2023to 28 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Philip Brown
Alison Yarnall, PhD
About this study
Official title: 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.
Read the 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 411 PD participants from the CVS PD cohort and 240 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.
- Conditions
- Parkinson Disease, Aging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 36 months
Change in fall frequency in PD
Change in fall frequency (in previous 6 months) in PD data
Measured: 36 months
Secondary outcomes (5)
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)
Measured: 36 months (PD) and 12 months (control)
Fall frequency in controls
Change in fall frequency (in previous 6 months) in control data
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start17 May 2023
- Primary completion28 Jul 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 651 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University of Kiel, University Hospital Erlangen, Tel-Aviv Sourasky Medical Center, University College Dublin
- Responsible party
- Sponsor
- Investigators
- Alison Yarnall, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874739
- Sponsor's protocol ID
- 10402
- Other IDs
- MJFF-022735, MJFF-022736, 323855
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full anonymised dataset will be made available on the Mobilise-D platform
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a Digital Mobility Assessment in Parkinson's Disease Using Wearable Technology - the Mobilise-D Extension Study.
- ClinicalTrials.gov ID
- NCT05874739
- Acronym / sponsor ID
- 10402
- Conditions
- Parkinson Disease, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 651 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- KU Leuven, University of Kiel, University Hospital Erlangen, Tel-Aviv Sourasky Medical Center, University College Dublin
- Study start
- 17 May 2023 (actual)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 411 PD participants from the CVS PD cohort and 240 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in LLFDI in controls
Time frame: 12 months
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).
Change in LLFDI in PD
Time frame: 36 months
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).
Change in fall frequency in PD
Time frame: 36 months
Change in fall frequency (in previous 6 months) in PD data
5 secondary outcomes
Difference in Real Walking Speed
Time frame: 36 months (PD) and 12 months (control)
Fall frequency in controls
Time frame: 12 months
Ability of Real Walking Speed to detect change in PD severity
Time frame: 36 months
Ability of Real Walking Speed to predict change in physical capacity
Time frame: 36 months (PD) and 12 months (control)
Ability of Real Walking Speed to predict change in PD severity
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Yes. The full anonymised dataset will be made available on the Mobilise-D platform
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Yarnall, PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Aging, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel K Neatrour, MSc (+44 (0) 191 2081406, isabel.neatrour@newcastle.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LLFDI in controls (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.