Abstract
BACKGROUND: Encouraging upper limb use and increasing intensity of practice in rehabilitation are two important goals for optimizing upper limb recovery post stroke. Feedback from novel wearable sensors may influence practice behaviour to promote achieving these goals. A wearable sensor can potentially be used in conjunction with a virtually monitored home program for greater patient convenience, or due to restrictions that preclude in-person visits, such as COVID-19. This trial aims to (1) determine the efficacy of a virtual behaviour change program that relies on feedback from a custom wearable sensor to increase use and function of the upper limb post stroke; and (2) explore the experiences and perceptions of using a program coupled with wearable sensors to increase arm use from the perspective of people with stroke. METHODS: This mixed-methods study will utilize a prospective controlled trial with random allocation to immediate or 3-week delayed entry to determine the efficacy of a 3-week behaviour change program with a nested qualitative description study. The intervention, the Virtual Arm Boot Camp (V-ABC) features feedback from a wearable device, which is intended to increase upper limb use post stroke, as well as 6 virtual sessions with a therapist. Sixty-four adults within 1-year post stroke onset will be recruited from seven rehabilitation centres. All outcomes will be collected virtually. The primary outcome measure is upper limb use measured by grasp counts over 3 days from the wearable sensor (TENZR) after the 3-week intervention. Secondary outcomes include upper limb function (Arm Capacity and Movement Test) and self-reported function (Hand Function and Strength subscale from the Stroke Impact Scale). Outcome data will be collected at baseline, post-intervention and at 2 months retention. The qualitative component will explore the experiences and acceptability of using a home program with a wearable sensor for increasing arm use from the point of view of individuals with stroke. Semi-structured interviews will be conducted with participants after they have experienced the intervention. Qualitative data will be analysed using content analysis. DISCUSSION: This study will provide novel information regarding the efficacy and acceptability of virtually delivered programs to improve upper extremity recovery, and the use of wearable sensors to assist with behaviour change. TRIAL REGISTRATION: ClinicalTrials.gov NCT04232163 . January 18, 2020.