Validating digital mobility assessment using wearable technology

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD), Parkinson’s disease (PD), multiple sclerosis (MS), proximal femoral fracture (PFF), congestive heart failure (CHF); Not Applicable

• Registration Number: ISRCTN12246987
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Study Completion: 2021-12-14
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

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:

COPD:
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)

PD:
1. Aged 18+ years
2. Diagnosis of PD according to the Movement Disorders Society criteria

MS:
1. Aged 18+ years
2. Diagnosis of MS based on the revised McDonald’s criteria

PFF:
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

CHF:
1. =45 years of age
2. Diagnosis of chronic heart failure NYHA class II-IV

HA:
1. 65+ years of age

Exclusion Criteria

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

COPD:
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

PD:
1. Impaired mobility related to non-PD causes, as judged by the investigator

MS:
1. Impaired mobility related to non-MS causes, as judged by the investigator

PFF:
1. Impaired mobility related to non-PFF causes, as judged by the investigator

CHF:
1. History of COPD =GOLD III
2. Impaired mobility related to non-CHF causes, as judged by the investigator

HA:
1. Neurological, respiratory, cardiac or musculoskeletal conditions affecting the ability to walk independently without a walking aid

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 01/11/2022: <br><br>Walking speed data in the real-world measured using a single sensor in comparison to walking speed data collected using multi-sensor reference systems in the lab and in the home. The laboratory tasks (45 minutes) and the home environment measurement (2.5 hours unsupervised) take place within 9 days of each other. <br><br>_____<br><br>Previous primary outcome measure:<br><br>Walking speed in real-world settings, collected via the sensor during a 7-day continual recording of free-living activities in the home environment

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 01/11/2022: <br><br>Right and left step, stride, turning angle, cadence, distance walked, gait variability and symmetry, and other gait-related outcomes relevant in the real-world measured using a single sensor in comparison to multi-sensor reference systems in the lab and in the home. The laboratory tasks (45 minutes) and the home environment measurement (2.5 hours unsupervised) take place within 9 days of each other. <br><br>_____<br><br>Previous secondary outcome measures:<br><br>Right and left step, stride, turning angle, cadence, distance walked, gait variability and symmetry, and other gait-related outcomes relevant for assessments in real-world settings, collected via the sensor during a 7-day continual recording of free-living activities in the home environment