ISRCTN12051706已完成未知
Validating digital mobility assessment using wearable technology – the Mobilise-D Clinical Validation study
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 2,388 人开始时间: 2020年12月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 2,388
研究概览
简要总结
2022 Protocol article in https://doi.org/10.1371/journal.pone.0269615 (added 27/10/2022)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 19/07/2021:
- •All participants:
- •1. Adults aged 18 or over
- •2. Able to walk 4 meters independently with or without walking aids
- •3. Anticipated availability for repeated study visits over 24 months
- •4. Ability to consent and comply with any study specific procedures.
- •5. Willingness to wear the McRobert’s body sensor (DynaPort MoveMonitor)
- •6. Able to read and write in first language in the respective country
- •1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society
- •2. Hoehn & Yahr stage I-III.
- •1. A diagnosis of MS based on the revised McDonald’s criteria
- •2. EDSS score of 3.0 - 6.5
- •3. Clinical evidence of disability worsening over the previous two years
- •COPD Cohort:
- •1. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio <0.70
- •2, Clinical stability, defined as at least 4 weeks after the onset of the last exacerbation
- •3. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
- •PFF Cohort:
- •1. Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery
- •2. Aged 45 years or older
- •Previous inclusion criteria:
- •All participants:
- •1. Adults aged 18 or over
- •2. Able to walk 4 meters independently with or without walking aids
- •3. Anticipated availability for repeated study visits over 24 months
- •4. Ability to consent and comply with any study specific procedures.
- •5. Willingness to wear the McRobert’s body sensor (DynaPort MoveMonitor)
- •6. Able to read and write in first language in the respective country
- •1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society
- •2. Hoehn & Yahr stage I-III.
- •1. A diagnosis of MS based on the revised McDonald’s criteria
- •2. EDSS score of 3.0-6.5.
- •3. Evidence of confirmed disability progression within the 12 months prior to screening (defined by a 6-month
- •confirmed EDSS increase of 1.0-point for participants if the EDSS score was 3.0 to 5.5 and a 0.5-point if the EDSS score was 6.0 to 6.5).
- •COPD Cohort:
- •1. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio <0.70
- •2, Clinical stability, defined as at least 4 weeks after the onset of the last exacerbation
- •3. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
- •PFF Cohort:
- •1. Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery
- •2. Aged 45 years or older (added 14/04/2021)
排除标准
- •All participants:
- •1. 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.
- •1. History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria)
- •2. Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of ‘vascular parkinsonism’
- •3. Drug-induced Parkinsonism
- •1. Clinical relapse within 30 days prior to screening and baseline.
- •COPD Cohort:
- •1. Having undergone major lung surgery (e.g. lung transplant)
- •2. Current diagnosis of lung cancer
- •3. Primary respiratory diseases other than COPD
- •4. Substantial limitations in mobility due to factors other than COPD
- •5. Lung volume reduction within 6 months before inclusion
- •PFF Cohort:
- •1. Not able to walk before treatment of hip fracture
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