Clinical validation of a mobility monitor to measure and predict health outcomes

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2388

Inclusion Criteria

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

PD Cohort:
1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society
2. Hoehn & Yahr stage I-III.

MS Cohort:
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

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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

PD Cohort:
1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society
2. Hoehn & Yahr stage I-III.

MS Cohort:
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)

Exclusion Criteria

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.

PD Cohort:
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

MS Cohort:
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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Validating digital mobility assessment using wearable technology

CompletedNot Applicable

ewcastle upon Tyne Hospitals NHS Foundation Trust

Updated 2/5/2024