Implementing technology-based exercises to enhance mobility and physical activity: Phase II of a feasibility hybrid type II randomised controlled trial.

The overall aim of this study was to determine the feasibility of conducting a large-scale implementation trial to determine if digital devices can be effectively implemented into routine physiotherapy practice in rehabilitation. The primary objective was to determine the feasibility of: 1) collecting dosage data on the amount of repetitive task-specific practice patients receive as part of physiotherapy; 2) recruiting patients into the trial; and 3) adherence to the protocol; i.e. for physiotherapists to use digital devices to prescribe exercises targeting mobility and physical activity for 30-60 minutes per session in addition to usual care.  Secondary aims were to determine the processes, resource use and management systems required to enable the conduct of a large-scale implementation trial, as well as explore implementation and patient-level outcomes for the future implementation trial. 

A pragmatic, assessor-blinded, feasibility hybrid type II implementation-effectiveness trial was undertaken at a public hospital in Australia. This trial had two phases. In Phase I physiotherapists received multifaceted implementation strategy guided by the Capabilities, Opportunities, Motivation-Behaviour (COM-B) model to use digital devices to provide exercises to improve mobility. In Phase II patients were randomised into control or intervention groups. Both groups received usual care, and the intervention group received additional exercises using digital devices provided by physiotherapists trained in Phase I. Primary feasibility outcomes were: documentation of exercise dosage, rate of recruitment, and physiotherapist’s ability to provide ≥30 mins exercise sessions using digital devices. 

Twenty-two patients (36% females, average age 63 (SD 16) years old, 91% stroke diagnosis) were randomised; 11 in each group. Exercise dosage was documented 100% of the time in the usual care and digital devices practice sheets, recruitment rate was 0.2 participants per week, and participants in the intervention group completed digital device sessions lasting an average of 29 (SD 6) mins, with only 4/11 (36%) achieving average session length greater than or equal to 30 mins. Participants in the intervention group trained on average 5 (SD 1) mobility tasks using an average 4 (SD 1) types of digital devices. Participants completed an average of 14 (SD 5) digital device sessions in 3 weeks with an average total number of exercise repetitions (median [IQR]) 3541 [2155 to 5003].

Exercises using digital devices can be delivered within usual rehabilitation staffing, but at a lower than intended dosage. Intervention and organisational implementation challenges were identified. Several sites would be needed for a future larger trial. 

This trial gave us important information in planning and conducting a future large- scale implementation-effectiveness trial in rehabilitation. The information collected on process, resource use and management systems could be used in planning and implementing other physiotherapy interventions in rehabilitation.