Multicentre pilot randomised control trial of a self-directed exergaming intervention for poststroke upper limb rehabilitation: research protocol.

INTRODUCTION: Technology-facilitated, self-directed upper limb (UL) rehabilitation, as an adjunct to conventional care, could enhance poststroke UL recovery compared with conventional care alone, without imposing additional resource burden. The proposed pilot randomised controlled trial (RCT) aims to assess whether stroke survivors will engage in self-directed UL training, explore factors associated with intervention adherence and evaluate the study design for an RCT testing the efficacy of a self-directed exer-gaming intervention for UL recovery after stroke. METHODS AND ANALYSIS: This is a multicentre, internal pilot RCT; parallel design, with nested qualitative methods. The sample will consist of stroke survivors with UL paresis, presenting within the previous 30 days. Participants randomised to the intervention group will be trained to use an exergaming device and will be supported to adopt this as part of their self-directed rehabilitation (ie, without formal support/supervision) for a 3-month period. The primary outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6 months poststroke. Secondary outcomes are the Action Research Arm Test (ARAT), the Barthel Index and the Modified Rankin Scale. Assessment time points will be prior to randomisation (0-1 month poststroke), 3 months and 6 months poststroke. A power calculation to inform sample size required for a definitive RCT will be conducted using FM-UE data from the sample across 0-6 months time points. Semistructured qualitative interviews will examine factors associated with intervention adoption. Reflexive thematic analysis will be used to code qualitative interview data and generate key themes associated with intervention adoption. ETHICS AND DISSEMINATION: The study protocol (V.1.9) was granted ethical approval by the Health Research Authority, Health and Care Research Wales, and the London- Harrow Research Ethics Committee (ref. 21/LO/0054) on 19 May 2021. Trial results will be submitted for publication in peer-reviewed journals, presented at national and international stroke meetings and conferences and disseminated among stakeholder communities. TRIAL REGISTRATION NUMBER: NCT04475692.

Examining Usability, Acceptability, and Adoption of a Self-Directed, Technology-Based Intervention for Upper Limb Rehabilitation After Stroke: Cohort Study.

BACKGROUND: Upper limb (UL) recovery after stroke is strongly dependent upon rehabilitation dose. Rehabilitation technologies present pragmatic solutions to dose enhancement, complementing therapeutic activity within conventional rehabilitation, connecting clinicians with patients remotely, and empowering patients to drive their own recovery. To date, rehabilitation technologies have been poorly adopted. Understanding the barriers to adoption may shape strategies to enhance technology use and therefore increase rehabilitation dose, thus optimizing recovery potential. OBJECTIVE: We examined the usability, acceptability, and adoption of a self-directed, exercise-gaming technology within a heterogeneous stroke survivor cohort and investigated how stroke survivor characteristics, technology usability, and attitudes toward technology influenced adoption. METHODS: A feasibility study of a novel exercise-gaming technology for self-directed UL rehabilitation in early subacute stroke survivors (N=30) was conducted in an inpatient, acute hospital setting. Demographic and clinical characteristics were recorded; participants' performance in using the system (usability) was assessed using a 4-point performance rating scale (adapted from the Barthel index), and adherence with the system was electronically logged throughout the trial. The technology acceptance model was used to formulate a survey examining the acceptability of the system. Spearman rank correlations were used to examine associations between participant characteristics, user performance (usability), end-point technology acceptance, and intervention adherence (adoption). RESULTS: The technology was usable for 87% (n=26) of participants, and the overall technology acceptance rating was 68% (95% CI 56%-79%). Participants trained with the device for a median of 26 (IQR 16-31) minutes daily over an enrollment period of 8 (IQR 5-14) days. Technology adoption positively correlated with user performance (usability) (ρ=0.55; 95% CI 0.23-0.75; P=.007) and acceptability as well as domains of perceived usefulness (ρ=0.42; 95% CI 0.09-0.68; P=.03) and perceived ease of use (ρ=0.46; 95% CI 0.10-0.74; P=.02). Technology acceptance decreased with increased global stroke severity (ρ=-0.56; 95% CI -0.79 to -0.22; P=.007). CONCLUSIONS: This technology was usable and acceptable for the majority of the cohort, who achieved an intervention dose with technology-facilitated, self-directed UL training that exceeded conventional care norms. Technology usability and acceptability were determinants of adoption and appear to be mediated by stroke severity. The results demonstrate the importance of selecting technologies for stroke survivors on the basis of individual needs and abilities, as well as optimizing the accessibility of technologies for the target user group. Facilitating changes in stroke survivors' beliefs and attitudes toward rehabilitation technologies may enhance adoption. Further work is needed to understand how technology can be optimized to benefit those with more severe stroke.

Self-Directed Exergaming for Stroke Upper Limb Impairment Increases Exercise Dose Compared to Standard Care.

Background. One of the strongest modifiable determinants of rehabilitation outcome is exercise dose. Technologies enabling self-directed exercise offer a pragmatic means to increase dose, but the extent to which they achieve this in unselected cohorts, under real-world constraints, is poorly understood. Objective. Here we quantify the exercise dose achieved by inpatient stroke survivors using an adapted upper limb (UL) exercise gaming (exergaming) device and compare this with conventional (supervised) therapy. Methods. Over 4 months, patients presenting with acute stroke and associated UL impairment were screened at a single stroke centre. Participants were trained in a single session and provided with the device for unsupervised use during their inpatient admission. Results. From 75 patients referred for inpatient UL therapy, we recruited 30 (40%), of whom 26 (35%) were able to use the device meaningfully with their affected UL. Over a median enrolment time of 8 days (IQR: 5-14), self-directed UL exercise duration using the device was 26 minutes per day (median; IQR: 16-31), in addition to 25 minutes daily conventional UL therapy (IQR: 12-34; same cohort plus standard care audit; joint n = 50); thereby doubling total exercise duration (51 minutes; IQR: 32-64) relative to standard care (Z = 4.0, P <.001). The device enabled 104 UL repetitions per day (IQR: 38-393), whereas conventional therapy achieved 15 UL repetitions per day (IQR: 11-23; Z = 4.3, P <.001). Conclusion. Self-directed adapted exergaming enabled participants in our stroke inpatient cohort to increase exercise duration 2-fold, and repetitions 8-fold, compared to standard care, without requiring additional professional supervision.