ISRCTN12246987Completed未知

Validating digital mobility assessment using wearable technology – the Mobilise-D Technical Validation study

ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites111 target enrollmentStarted: March 24, 2020Last updated: February 5, 2024

Conditions

Trial Snapshot

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34857567/ (added 06/12/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36522646/ Protocol validation (added 16/12/2022) 2022 Preprint results in https://doi.org/10.21203/rs.3.rs-2088115/v1 Gait sequence detection, foot initial contact detection, cadence and stride length results (added 16/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37316858/ (added 15/06/2023) 2024 Results article in https://doi.org/10.1038/s41598-024-51766-5 (added 22/01/2024)

•All groups:
•1. Able to walk 4 meters independently with or without walking aids
•2. Able to give informed consent
•3. Willingness to wear the sensor set-ups during the study
•4. Shoe size 36 (3 UK) or above
•5. Able to read and write in first language in the respective country
•6. MoCA >154
•7. Available for home visit/office during study period
•Each disease cohort has specific inclusion criteria:
•1. =45 years of age
•2. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio <0.70)
•3. Clinical stability, defined as at least 4 weeks without antibiotics and/or oral corticosteroids to treat either a moderate or severe exacerbation
•4. 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)
•1. Aged 18+ years
•2. Diagnosis of PD according to the Movement Disorders Society criteria
•1. Aged 18+ years
•2. Diagnosis of MS based on the revised McDonald’s criteria
•1. 65+ years of age
•2. 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 within last 12 months
•1. =45 years of age
•2. Diagnosis of chronic heart failure NYHA class II-IV
•1. 65+ years of age

•All groups:
•1. The occurrence of any of the following with 3 months prior to inclusion: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD)
•2. Current medical condition that could interfere with the patient’s compliance
•1. Having undergone major lung surgery (e.g. lung volume reduction, lung transplant)
•2. Having a lung tumor
•3. Primary respiratory diseases other than COPD
•4. Impaired mobility related to non-COPD causes, as judged by the investigator
•1. Impaired mobility related to non-PD causes, as judged by the investigator
•1. Impaired mobility related to non-MS causes, as judged by the investigator
•1. Impaired mobility related to non-PFF causes, as judged by the investigator
•1. History of COPD =GOLD III
•2. Impaired mobility related to non-CHF causes, as judged by the investigator
•1. Neurological, respiratory, cardiac or musculoskeletal conditions affecting the ability to walk independently without a walking aid

Sponsor

ewcastle upon Tyne Hospitals NHS Foundation Trust