Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05874739
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-03-29
Brief Title:
Mobilise-D Extension Study
Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Organization:
Newcastle-upon-Tyne Hospitals NHS Trust
Study Overview
Official Title:
Validating a Digital Mobility Assessment in Parkinsons Disease Using Wearable Technology - the Mobilise-D Extension Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to investigate the ability of a mobility monitor to measure and predict outcomes in Parkinsons 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 Parkinsons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 323855 | OTHER | IRAS | None |
| MJFF-022735 | OTHER_GRANT | None | None |
| MJFF-022736 | OTHER_GRANT | None | None |