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Protocol
Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke
  1. Gianpaolo Fusari1,2,
  2. Ella Gibbs2,
  3. Lily Hoskin2,
  4. Daniel Dickens2,
  5. Melanie Leis3,
  6. Elizabeth Taylor4,
  7. Fiona Jones4,
  8. Ara Darzi2
  1. 1Helix Centre, Royal College of Art, London, UK
  2. 2Helix Centre, Imperial College London, London, UK
  3. 3Big Data and Analytical Unit, Institute of Global Health Innovation, Imperial College London, London, UK
  4. 4Faculty of Health Social Care and Education, Kingston and St George's University of London, London, UK
  1. Correspondence to Gianpaolo Fusari; gianpaolo{at}helixcentre.com

Abstract

Introduction Arm weakness is a common problem after stroke (affecting 450 000 people in the UK) leading to loss of independence. Repetitive activity is critical for recovery but research shows people struggle with knowing what or how much to do, and keeping track of progress. Working with more than 100 therapists (occupational therapists and physiotherapists) and patients with stroke, we codeveloped the OnTrack intervention—consisting of software for smart devices and coaching support—that has the potential to address this problem. This is a protocol to assess the feasibility of OnTrack for evaluation in a randomised control trial.

Methods and analysis A mixed-method, single-arm study design will be used to evaluate the feasibility of OnTrack for hospital and community use. A minimum sample of 12 participants from a stroke unit will be involved in the study for 14 weeks. During week 1, 8 and 14 participants will complete assessments relating to their arm function, arm impairment and activation. During weeks 2–13, participants will use OnTrack to track their arm movement in real time, receive motivational messages and face-to-face sessions to address problems, gain feedback on activity and receive self-management skills coaching. All equipment will be loaned to study participants. A parallel process evaluation will be conducted to assess the intervention’s fidelity, dose and reach, using a mixed-method approach. A public and patient involvement group will oversee the study and help with interpretation and dissemination of qualitative and quantitative data findings.

Ethics and dissemination Ethical approval granted by the National Health Service Health Research Authority, Health and Care Research Wales, and the London—Surrey Research Ethics Committee (ref. 19/LO/0881). Trial results will be submitted for publication in peer review journals, presented at international conferences and disseminated among stroke communities. The results of this trial will inform development of a definitive trial.

Trial registration number NCT03944486.

  • stroke
  • rehabilitation medicine
  • neurology
  • public health
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Footnotes

  • Twitter @ElizaTay1, @JonesFio

  • Contributors AD is grant holder and has project oversight along with DD. GF, EG and LH developed the intervention and conceived of the study. GF, EG, and FJ initiated the study design and ET and ML helped with further refinement. EG and GF are responsible for delivering the intervention and data collection. FJ and ET are responsible for the process evaluation. ML provides statistical expertise in trial design and is conducting the primary statistical analysis. All authors contributed to the refinement of the study protocol and approved the final manuscript.

  • Funding This study is funded by the NIHR Imperial Biomedical Research Centre, grant 1215-20013. All intellectual property associated with the OnTrack system is owned by the Helix Centre which is a collaboration between Imperial College London and the Royal College of Art.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

  • Competing interests FJ is the founder of the social enterprise Bridges Self-Management. She has not received any financial support for this work that could have influenced the design.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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