Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke

Gianpaolo Fusari, Ella Gibbs, Lily Hoskin, Daniel Dickens, Melanie Leis, Elizabeth Taylor, Fiona Jones, Ara Darzi, Gianpaolo Fusari, Ella Gibbs, Lily Hoskin, Daniel Dickens, Melanie Leis, Elizabeth Taylor, Fiona Jones, Ara Darzi

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.

Keywords: neurology; public health; rehabilitation medicine; stroke.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Trial diagram. NHS, National Health Service.
Figure 2
Figure 2
Logic model.
Figure 3
Figure 3
Examples of visualisations created using aggregated data captured by OnTrack from healthy beta testers. Data for a minimum of 5 and a maximum of 18 days were aggregated for the period between June and August 2019.

References

    1. WHO The atlas of heart disease and stroke. Available: [Accessed 04 Oct 2019].
    1. Stroke Association State of the Nation: stroke statistics. Stroke Association, 2018.
    1. Salter K, Hellings C, Foley N, et al. . The experience of living with stroke: a qualitative meta-synthesis. J Rehabil Med 2008;40:595–602. 10.2340/16501977-0238
    1. Care Quality Commission Supporting life after stroke: a review of services for people who have had a stroke and their carers. London: Care Quality Commission, 2011.
    1. Pollock A, Farmer SE, Brady MC, et al. . Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev 2014;23 10.1002/14651858.CD010820.pub2
    1. Pollock A, St George B, Fenton M, et al. . Top 10 research priorities relating to life after stroke--consensus from stroke survivors, caregivers, and health professionals. Int J Stroke 2014;9:313–20. 10.1111/j.1747-4949.2012.00942.x
    1. Kunkel D, Fitton C, Burnett M, et al. . Physical inactivity post-stroke: a 3-year longitudinal study. Disabil Rehabil 2015;37:304–10. 10.3109/09638288.2014.918190
    1. Bernhardt J, Dewey H, Thrift A, et al. . Inactive and alone: physical activity within the first 14 days of acute stroke unit care. Stroke 2004;35:1005–9. 10.1161/01.STR.0000120727.40792.40
    1. Laver KE, Lange B, George S, et al. . Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev 2017;11:CD008349 10.1002/14651858.CD008349.pub4
    1. Loureiro RCV, Harwin WS, Nagai K, et al. . Advances in upper limb stroke rehabilitation: a technology push. Med Biol Eng Comput 2011;49:1103–18. 10.1007/s11517-011-0797-0
    1. Jones F, Gage H, Drummond A, et al. . Feasibility study of an integrated stroke self-management programme: a cluster-randomised controlled trial. BMJ Open 2016;6:e008900 10.1136/bmjopen-2015-008900
    1. Harwood M, Weatherall M, Talemaitoga A, et al. . Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life – a randomized controlled trial. Clin Rehabil 2012;26:493–501. 10.1177/0269215511426017
    1. Kendall E, Catalano T, Kuipers P, et al. . Recovery following stroke: the role of self-management education. Soc Sci Med 2007;64:735–46. 10.1016/j.socscimed.2006.09.012
    1. Grady PA, Gough LL. Self-Management: a comprehensive approach to management of chronic conditions. Am J Public Health 2014;104:e25–31. 10.2105/AJPH.2014.302041
    1. Esmonde T, McGinley J, Wittwer J, et al. . Stroke rehabilitation: patient activity during non-therapy time. Aust J Physiother 1997;43:43–51. 10.1016/S0004-9514(14)60401-3
    1. Buckland D. Leaving hospital is ‘like falling off a cliff’ for stroke survivors. Raconteur. APRIL 27, 2017. Available: [Accessed 04 Oct 2019].
    1. McKevitt C, Fudge N, Redfern J, et al. . Self-Reported long-term needs after stroke. Stroke 2011;42:1398–403. 10.1161/STROKEAHA.110.598839
    1. Woodman P, Riazi A, Pereira C, et al. . Social participation post stroke: a meta-ethnographic review of the experiences and views of community-dwelling stroke survivors. Disabil Rehabil 2014;36:2031–43. 10.3109/09638288.2014.887796
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Billingham SAM, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom clinical research network database. BMC Med Res Methodol 2013;13:104 10.1186/1471-2288-13-104
    1. Bridges Self-Management Limited Bridges self-management. Available: [Accessed 07 Oct 2019].
    1. Medical Research Institute of New Zealand Taking charge after stroke (TaCAS). Available: [Accessed 07 oct 2019].
    1. DOCUMAS DOCUMAS: efficient health research management. Available: [Accessed 04 Oct 2019].
    1. Hibbard J, Gilburt H. Supporting people to manage their health An introduction to patient activation. London: The Kings Fund, 2014.
    1. Hibbard JH, Stockard J, Mahoney ER, et al. . Development of the patient activation measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res 2004;39:1005–26. 10.1111/j.1475-6773.2004.00269.x
    1. Roberts NJ, Kidd L, Dougall N, et al. . Measuring patient activation: the utility of the patient activation measure within a UK context-Results from four exemplar studies and potential future applications. Patient Educ Couns 2016;99:1739–46. 10.1016/j.pec.2016.05.006
    1. Sahlgrenska Academy Institute of Neuroscience and Physiology, University of Gothenburg Fugl-Meyer. Available: [Accessed 04 Oct 2019].
    1. Duncan PW, Propst M, Nelson SG. Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther 1983;63:1606–10. 10.1093/ptj/63.10.1606
    1. Uswatte G, Taub E, Morris D, et al. . Reliability and validity of the upper-extremity motor activity Log-14 for measuring real-world arm use. Stroke 2005;36:2493–6. 10.1161/01.STR.0000185928.90848.2e
    1. Quinn TJ, Dawson J, Walters MR, et al. . Exploring the reliability of the modified Rankin scale. Stroke 2009;40:762–6. 10.1161/STROKEAHA.108.522516
    1. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain 1986;27:117–26. 10.1016/0304-3959(86)90228-9
    1. Nasreddine ZS, Phillips NA, Bédirian V, et al. . The Montreal cognitive assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005;53:695–9. 10.1111/j.1532-5415.2005.53221.x
    1. Fullerton KJ, McSherry D, Stout RW. Albert's test: a neglected test of perceptual neglect. Lancet 1986;1:430 10.1016/s0140-6736(86)92381-0
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 10.1016/0168-8510(90)90421-9
    1. England NHS. The Friends and Family Test. England: NHS, 2014.
    1. Anon SUS: A 'Quick and Dirty' Usability Scale : Usability evaluation in industry. CRC Press, 1996: 207–12.
    1. Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: medical Research Council guidance. BMJ 2015;350:h1258 10.1136/bmj.h1258
    1. Kellogg Foundation WK. Logic model development guide. Battle Creek, Michigan: W. K. Kellogg Foundation, 2004.
    1. The Scottish Government Designing and evaluating behaviour change interventions. The Scottish Government, 2015.
    1. Kislov R, Pope C, Martin GP, et al. . Harnessing the power of theorising in implementation science. Implement Sci 2019;14:103 10.1186/s13012-019-0957-4
    1. QSR International Ltd NVIVO. Available: [Accessed 07 Oct 2019].
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. National Institute for Health Research About INVOLVE. Available: [Accessed 04 Oct 2019].

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe