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

Abstract

IntroductionArm 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 analysisA 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 disseminationEthical 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 numberNCT03944486.

What is the feasibility and patient acceptability of a digital system for arm and hand rehabilitation after stroke? A mixed-methods, single-arm feasibility study of the ‘OnTrack’ intervention for hospital and home use

“…The study met its objectives in assessing the acceptability and feasibility of the intervention and trial procedures. Despite being affected by the pandemic, recruitment to the trial was in line with prestudy expectations as described in the protocol’s sample size calculation, 23 as well as participant retention rates. Appropriate outcome measures and sample size estimations for an RCT were analysed.…”

“…Participant inclusion and exclusion criteria are fully defined in the study protocol 23 ; briefly, participants were adults with a stroke diagnosis less than 6 months previously (first or recurrent) requiring arm and hand rehabilitation in hospital and/or at home, medically stable, presenting without arm pain or oedema, and with capacity to consent.…”

“…As per study protocol, 23 recruitment, adherence and retention rates were measured, as well as reasons for declining participation or withdrawing from the trial; the utility and completion of outcome measures to provide an indication of effectiveness to inform sample size calculations for an RCT; the usability of OnTrack by study participants; and the acceptability of study procedures by front-line staff. An independent process evaluation assessed the fidelity of the intervention delivery as well as the acceptability of the intervention to participants and delivery team.…”

Practitioner-led, peer-group sports intervention combined with a context-focused intervention for children with cerebral palsy: a protocol of a feasibility randomised clinical trial

“…In terms of recruitment, experienced clinicians at the trial site have predicted that 50% of eligible patients will agree to participate and complete the research study. Therefore, we plan to identify at least 36 potential participants to reach our target sample (n=18) 24 26…”

Is a novel digital system for arm and hand rehabilitation suitable for stroke survivors? A qualitative process evaluation of OnTrack

“…All participant sessions were open to observation by the process evaluation researchers, who selected sessions based on the need to observe a range of session types with a range of participants. We aimed to interview all OnTrack participants for the process evaluation—and thus the sample size was determined by what was required for the feasibility study using guidelines that advocate a sample size between 12 and 30 14…”