Validating a Digital Mobility Assessment in Parkinson's Disease Using Wearable Technology - the Mobilise-D Extension Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 651
- 试验地点
- 1
- 主要终点
- Change in LLFDI in PD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •Inclusion Criteria:
- •Participant in the Mobilise-D Clinical Validation Study (CVS) PD Cohort - see below.
- •CVS PD Cohort:
- •Inclusion criteria:
- •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
- •Exclusion Criteria:
- •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
结局指标
主要结局
Change in LLFDI in PD
时间窗: 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
时间窗: 36 months
Change in fall frequency (in previous 6 months) in PD data
Change in LLFDI in controls
时间窗: 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).
次要结局
- Fall frequency in controls(12 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)
- Ability of Real Walking Speed to detect change in PD severity(36 months)
- Difference in Real Walking Speed(36 months (PD) and 12 months (control))