Abstract
BackgroundEncouraging 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.govNCT04232163. January 18, 2020.
Highlights
Encouraging upper limb use and increasing intensity of practice in rehabilitation are two important goals for optimizing upper limb recovery post stroke
The components of the Virtual Arm Boot Camp (V-ABC) were designed to address considerations outlined in the Capability, Opportunity, Motivation, Behaviour Model applied to affected upper limb use after stroke [14]
The integration of wearable sensors with rehabilitation programs is in its infancy
Summary
This nested mixed-methods study will be comprised of a multi-centre, site-stratified, assessor blinded, parallel group, randomized controlled superiority trial with a 1:1 allocation ratio with an embedded qualitative study [11]. The components of the V-ABC were designed to address considerations outlined in the Capability, Opportunity, Motivation, Behaviour Model applied to affected upper limb use after stroke [14]. The information for this table was obtained from the literature and through our experience studying upper limb use post stroke. Evaluators will be occupational or physical therapists who will participate in about 4 h of training (reviewing materials and an online training session) They will be blinded to group allocation of the participant, i.e. immediate vs delayed. Data entry will be carried out by a research assistant, with electronic range checks for data values, and verified by a member of the steering
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