Additional arm-hand boost therapy (AHA-BOOST) in an inpatient rehabilitation setting during the subacute phase after stroke: protocol for a randomised controlled trial including a clinical, process and health economic evaluation.

introductionA considerable number of patients present with an upper limb impairment after stroke, which has a significant impact on daily life activities and quality of life. Currently, based on a Cochrane review, there is no high-quality evidence for any of the upper limb interventions used in routine practice. Therefore, the Jessa Hospital developed an additional arm-hand boost programme (AHA-BOOST), a novel, stratified intervention that integrates neurophysiological knowledge with an early start to optimise poststroke upper limb recovery. METHODS AND ANALYSIS: This multicentre randomised controlled trial with parallel design compares AHA-BOOST with a dose-matched programme for the lower limbs. Both interventions are in addition to usual care and consist of a combination of group sessions (1 hour per day, 5 times per week) and individualised therapy (two 30 min sessions per week) provided over 4 weeks. In total, 80 subacute stroke patients will be recruited from five rehabilitation centres in Belgium and randomised to one of both interventions. Patients will be followed up until 12 months post stroke to support a cost-utility analysis and assess long-term clinical effects of the programme. Various outcomes are collected at different time points: preintervention, immediately post intervention, 3 months post intervention, 6 months post stroke and 12 months post stroke. The Action Research Arm Test is the clinical primary outcome. The secondary outcomes are: Fugl-Meyer assessment-upper extremity, Stroke Upper Limb Capacity Scale, Barthel Index, modified Rankin Scale, Stroke Impact Scale and EuroQoL 5D-5L (EQ-5D-5L). The clinical analysis includes a multivariate analysis of variance (MANOVA) analysis for comparing clinical changes between both groups and a subgroup analysis to explore the effects in different types of stroke survivors. Additionally, a process evaluation, guided by the Medical Research Council Framework, will assess key aspects of the implementation, including delivery (structures and resources), dose, reach, fidelity, adaptations, quality, mechanisms of change and the context. Both quantitative and qualitative data will be collected using the following tools during the intervention: therapy diaries for each session; video recordings of AHA-BOOST group sessions and after the intervention using: interviews with patients, therapists and management. The qualitative data will be assessed using content and thematic analysis and the quantitative data with descriptive statistics. Ultimately, in addition to the EQ-5D-5L, direct and indirect healthcare costs are collected for the health economic evaluation. A cost-utility analysis will be performed with a time horizon of 12 months post stroke comparing both therapies, and a Markov model will assess the cost-effectiveness of AHA-BOOST on a lifetime horizon. To test the robustness of the results, sensitivity and scenario analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval has been obtained by different ethical committees (UZ/KU Leuven (central committee), UZ Gent, Gasthuiszusters Antwerpen and Maria Middelares). The study will be performed in accordance with the protocol, current International Council for Harmonisation (ICH) and Good Clinical Practice (ICH-GCP) guidelines, and applicable regulatory requirements. The current approved protocol is version 5, dated 7 May 2025. Protocol amendments will be submitted to all involved ethical committees. The study results will be disseminated through peer-reviewed publications, conference presentations and stakeholder reports. TRIAL REGISTRATION NUMBER: NCT06517251.