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Mobilise-D Technical Validation Study

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    270519

  • Contact name

    Lynn Rochestor

  • Contact email

    lynn.rochester@newcastle.ac.uk

  • Sponsor organisation

    The Newcastle upon Tyne Hospitals NHS Foundation Trust

  • Duration of Study in the UK

    0 years, 6 months, 0 days

  • Research summary

    The Mobilise-D Technical Validation Study is part of the EU-funded IMI project Mobilise-D. This project aims to link digital assessments of mobility to clinical outcomes for regulatory and clinical endorsement. This study comprises the first phase of this project and aims to carry out a technical validation of a device/algorithm pair to measure real-world walking speed and other digital mobility outcomes. The study is an observational design that will compare free-living gait speed and other digital outcomes against reference standards. The usability and acceptability of the devise from perspective of participants and researchers will also be evaluated.

    120 participants representing the disease cohorts of interest to MOBILISE-D partners will be recruited from six different groups: Chronic Obstructive Pulmonary Disease (COPD), Parkinson’s disease (PD), Multiple Sclerosis (MS), Proximal femoral fracture (PFF), Congestive Heart Failure (CHF) and healthy older adults (HA). Participants will be recruited from five clinical sites who have access to the populations of interest and have the capability to conduct technical studies and recruit the participants.

    The protocol includes: a) walking in a gait laboratory under both strictly controlled conditions and under simulated daily activities; b) unsupervised recording of a few hours of real-world daily activities in the participants own home/community; and c) seven days of unsupervised monitoring and interview follow-up to assess participant acceptability and compliance.

    During a) and b), gold-standard technologies will be used which will include the optimal combination of sensors appropriate for each setting. The accuracy of the device/algorithm pair to measure real-world walking speed and other digital mobility outcomes will be established by comparison to the gold-standard to determine criterion validity of the digital outcomes. Wearability and compliance will be addressed using a combination of quantitative and qualitative techniques, including System Usability Scale and semi-structured interviews with users.

  • REC name

    London - Bloomsbury Research Ethics Committee

  • REC reference

    19/LO/1507

  • Date of REC Opinion

    11 Nov 2019

  • REC opinion

    Further Information Favourable Opinion