UPBEAT Trial: a randomised feasibility evaluation of a digital system for UPper limB rEhabilitation After sTroke

Stroke rehabilitation is essential, yet many stroke survivors receive insufficient therapy, particularly for arm function. The 2023 UK National Stroke Guidelines recommend ongoing rehabilitation, but resource constraints limit therapy intensity. Digital interventions, such as OnTrack-a wearable system co-designed with stroke survivors, carers and therapists-offer a scalable self-management solution for rehabilitation. This study evaluates the feasibility of implementing OnTrack within NHS stroke services and informs a future RCT.

A two-arm, parallel-group randomised feasibility trial conducted across three NHS sites. Stroke survivors (n = 30) with arm weakness within 12 months post-stroke were randomised 1:1 to receive either OnTrack plus usual care or usual care alone. The primary outcome was the recruitment rate. Secondary feasibility outcomes included retention, adherence, and intervention fidelity. Secondary clinical measures assessed arm function (MAL-14), self-efficacy (SSEQ), quality of life (EQ-5D-5L), and usability (SUS). A process evaluation explored intervention fidelity and implementation experiences. A preliminary economic evaluation examined data collection feasibility using the Client Service Receipt Inventory (CSRI) and a per-patient costing of the OnTrack intervention.

Thirty participants out of a target of 42 (71.4%) were randomised, with 24/30 (80%) retained at 12 weeks. Intervention adherence was high with participants engaging with OnTrack an average of 6.3 days per week (90.7%). Fidelity of intervention delivery was modest (53.9%), highlighting areas for therapist training improvements. Trends suggested improvements in arm function and self-efficacy across groups. The preliminary economic evaluation confirmed the feasibility of data collection using CSRI, though limitations in accuracy and completeness were identified. A per-patient costing of the OnTrack intervention was achieved. Apparent cost differences between groups, identified through a preliminary cost-consequence analysis, were influenced by an unbalanced distribution of reported service use and should be interpreted with caution.

UPBEAT demonstrated the feasibility of delivering OnTrack in NHS stroke services, with strong retention and adherence. Findings support the potential for a future full-scale RCT, with refinements needed in recruitment procedures, therapist training, and economic data collection methods. Digital self-management tools like OnTrack may offer a scalable approach to increasing rehabilitation intensity, addressing gaps in stroke recovery pathways.

UPBEAT Feasibility Trial, IRAS: 323576, CPMS: 59352. Approved by London Surrey REC on 14/12/2023.