Implementing digital devices to increase mobility training for people receiving inpatient rehabilitation: protocol for a feasibility hybrid type II randomised controlled trial

Abstract

Abstract Background People with mobility limitations can benefit from rehabilitation programs incorporating intensive, repetitive, and task-specific exercises using digital devices such as virtual reality gaming systems, tablet and smartphone applications, and wearable devices. The Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial (n = 300) showed improvements in mobility in people using these types of digital devices in addition to their usual rehabilitation care when the intervention was provided by an additional study-funded physiotherapist. However, it is not clear if this intervention can be implemented by hospital physiotherapists with a usual clinical load. The AMOUNT Implementation trial aims to explore the feasibility of conducting a large-scale implementation trial. Methods A pragmatic, assessor blinded, feasibility hybrid type II randomised controlled trial will be undertaken at a public hospital in Australia. There will be two phases. Phase I (or the Implementation Phase) will involve implementing the digital devices into physiotherapy practice. Physiotherapists from the rehabilitation ward will receive a multifaceted implementation strategy guided by the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model. This implementation strategy consists of identifying and training a clinical champion; providing digital devices and changing the physical structure of the work space; providing education and training in use of devices; facilitating use of the digital devices through clinical reasoning sessions and journal clubs; auditing the recording of exercise dosage and providing feedback to the physiotherapists. Phase II (or the Trial Phase) will involve randomising 30 eligible inpatients from the same ward into either usual care or usual care plus an additional 30 minutes or more of exercises using digital devices. This intervention will be provided by the physiotherapists who took part in the implementation phase. We will collect data on feasibility, implementation, and patient-level clinical outcomes. The three primary outcome measures are: the extent to which physiotherapists document the dosage of exercises provided to participants; ability to recruit participants; and fidelity to the protocol of using digital devices to prescribe exercises. Discussion This feasibility study will provide important information to guide the planning and conduct of a future large-scale implementation trial. Trial registration : Australian and New Zealand Clinical Trial Registry; ACTRN12621000938808; registered 19/07/2021.