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[ARTICLE] Evaluation of a smartwatch-based intervention providing feedback of daily activity within a research-naive stroke ward: a pilot randomised controlled trial – Full Text

Abstract

Background

The majority of stroke patients are inactive outside formal therapy sessions. Tailored activity feedback via a smartwatch has the potential to increase inpatient activity. The aim of the study was to identify the challenges and support needed by ward staff and researchers and to examine the feasibility of conducting a randomised controlled trial (RCT) using smartwatch activity monitors in research-naive rehabilitation wards. Objectives (Phase 1 and 2) were to report any challenges and support needed and determine the recruitment and retention rate, completion of outcome measures, smartwatch adherence rate, (Phase 2 only) readiness to randomise, adherence to protocol (intervention fidelity) and potential for effect.

Methods

First admission, stroke patients (onset < 4 months) aged 40–75, able to walk 10 m prior to stroke and follow a two-stage command with sufficient cognition and vision (clinically judged) were recruited within the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Phase 1: a non-randomised observation phase (to allow practice of protocol)—patients received no activity feedback. Phase 2: a parallel single-blind pilot RCT. Patients were randomised into one of two groups: to receive daily activity feedback over a 9-h period or to receive no activity feedback. EQ-5D-5L, WHODAS and RMI were conducted at baseline, discharge and 3 months post-discharge. Descriptive statistics were performed on recruitment, retention, completion and activity counts as well as adherence to protocol.

Results

Out of 470 ward admissions, 11% were recruited across the two phases, over a 30-week period. Retention rate at 3 months post-discharge was 48%. Twenty-two percent of patients dropped out post-baseline assessment, 78% completed baseline and discharge admissions, from which 62% were assessed 3 months post-discharge. Smartwatch data were received from all patients. Patients were correctly randomised into each RCT group. RCT adherence rate to wearing the smartwatch was 80%. Baseline activity was exceeded for 65% of days in the feedback group compared to 55% of days in the no feedback group.

Conclusions

Delivery of a smartwatch RCT is feasible in a research-naive rehabilitation ward. However, frequent support and guidance of research-naive staff are required to ensure completeness of clinical assessment data and protocol adherence.

Background

Exercise has an important role in the recovery of stroke, increasing cognition, arm function, balance and gait, in addition to reducing the risk of subsequent cardiovascular events []. Despite the importance of general physical activity in recovery, the majority of stroke survivors receiving rehabilitation in hospital are inactive outside formal therapy sessions []. In order to encourage long-term exercise adherence, it is recommended that physical activity goals are customised to the individual tolerance of the stroke patient [].

Modern electronic activity monitors are able to provide a wide range of behavioural monitoring tools and are therefore emerging as a possible method to provide customised activity goals and feedback to promote exercise []. Coinciding with the technological developments in activity monitoring, there is evidence to suggest that activity feedback of exercise may increase motivation to exercise. The provision of activity feedback has been found to be more effective in increasing physical activity levels than providing activity goals alone, in healthy controls [] and in older adults undergoing rehabilitation []. Interventions providing feedback and monitoring of activity have shown positive outcomes in relation to exercise adherence amongst older individuals []. However, personalised activity feedback has also found to have no effect on actual or intended activity levels amongst controls []. Despite studies suggesting a positive effect, more evidence is needed before such activity feedback interventions can be recommended to be used in treatment.

The literature has shown that remote monitoring of physical activity is feasible after stroke []; however, the impact of activity feedback on exercise levels within this population is less clear. A systematic review of studies investigating augmented feedback on motor activities after stroke concluded that findings were inconsistent due to the combination of multiple aspects and types of augmented feedback used []. One study found that feedback of physical activity provided three times a week had no significant effect on the daily walking time of stroke inpatients []. Little research to date has investigated the use of periodic feedback of daily activity amongst stroke patients undergoing rehabilitation. It is of interest to see whether increasing the frequency of activity feedback will elicit greater physical activity levels. The provision of daily activity feedback (via a smartwatch), relative to activity at fixed time points through-out the previous day, may have the potential to motivate stroke rehabilitation patients to be more active.

Conducting clinical trials within research-naive settings are commonly accompanied with ethical, cultural and organisational challenges []. The present study will evaluate the feasibility of conducting the smartwatch intervention mentioned above within a research-naive stroke rehabilitation centre in Hefei, China (whereby no rehabilitation research has previously been conducted).

The aim of this feasibility study was to identify the challenges and support needed by ward staff and researchers and to examine the feasibility of conducting an RCT using smartwatch activity monitors in research-naive rehabilitation wards. The objectives were to report any challenges and support needed and determine the recruitment and retention rate, completion of outcome measures, adherence to wearing the smartwatch, readiness to randomise, adherence to protocol (intervention fidelity) and potential for effect.[…]

 

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Activity feedback as displayed on the smartwatch screen for the feedback group (a), which included both the feedback bars and clock face, and the no feedback (control) group (b), which included the clock face only

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