Mobilise-D: Extension Study

Status Recruiting

Clinical 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 of age matched control participants. The data will inform researchers about PD disease progression and normal changes in mobility associated with aging.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05874739
Study type	Observational
Source	Newcastle-upon-Tyne Hospitals NHS Trust
Contact	Isabel K Neatrour, MSc
Phone	+44 (0) 191 2081406
Email	isabel.neatrour@newcastle.ac.uk
Status	Recruiting
Phase
Start date	May 17, 2023
Completion date	July 28, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05415774` - Combined Deep Brain Stimulation in Parkinson's Disease	N/A
Recruiting	`NCT04691661` - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease	Phase 2
Active, not recruiting	`NCT05754086` - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed	`NCT04045925` - Feasibility Study of the Taïso Practice in Parkinson's Disease	N/A
Recruiting	`NCT04194762` - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation	N/A
Completed	`NCT02705755` - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)	Phase 2
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT05830253` - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting	`NCT03272230` - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System	N/A
Recruiting	`NCT06139965` - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed	`NCT04580849` - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease	N/A
Completed	`NCT04477161` - Effect of Ketone Esters in Parkinson's Disease	N/A
Completed	`NCT03980418` - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam	N/A
Completed	`NCT04942392` - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic	N/A
Terminated	`NCT03446833` - LFP Beta aDBS Feasibility Study	N/A
Completed	`NCT03497884` - Individualized Precise Localization of rTMS on Primary Motor Area	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT04997642` - Parkinson's Disease and Movement Disorders Clinical Database
Completed	`NCT04117737` - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson	N/A
Recruiting	`NCT03618901` - Rock Steady Boxing vs. Sensory Attention Focused Exercise	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.