Study protocol.

<div><p>Background</p><p>Occupational therapy (OT) is an effective evidence-based intervention that positively influences stroke patients’independence recovery, leading to new opportunities for better quality of life outcomes.</p><p>Objectives</p><p>To explore the effectiveness of an early OT intervention program (EOTIPS) in the process of hospital to home discharge after stroke in Spain.</p><p>Material and methods</p><p>We conducted a prospective, randomized controlled clinical trial that included 60 adults who suffered a stroke and were discharged home. Participants assigned to the experimental group (n = 30) were included in EOTIPS and compared with a control group (n = 30). Evaluations assessed quality of life (Stroke and Aphasia Quality of Life Scale [SAQOL-39]), functional independence (Modified Rankin Scale [mRS], Barthel Index [BI] and Stroke Impact Scale-16 [SIS-16]), perceptual-cognitive skills (Montreal Cognitive Assessment [MoCA]), upper limb function (Fugl Meyer Assessment [FMA]), mobility (Berg Balance Scale [BBS] and Timed Up & Go [TUG]), communication skills (Communicative Activity Log [CAL]) and mood disorders (Beck Depression Inventory–II [BDI-II] and Hamilton Anxiety Scale [HAM-A]); they were completed within two weeks post-stroke and after three months follow-up. Statistical analysis included intent-to-treat analysis, considering all participants (dropouts as failures), and efficacy analysis, considering only end-of-treatment participants.</p><p>Results</p><p>Participants in the intervention group showed a significant better evolution in the main outcome measure of quality of life (SAQOL-39 <i>p</i> = .029), as well as for independence (mRS<i>p</i> = .004), perceptual-cognitive skills (MoCA <i>p</i> = .012)and symptoms of depression (BDI-II <i>p</i> = .011) compared to the control group.</p><p>Conclusions</p><p>EOTIPS was effective in improving quality of life, as well as enhancing perceptual-cognitive skills, independence and reducing levels of depression for patients who suffered a stroke in a Spanish cohort and could be considered as an applicable non-pharmacologic therapeutic tool that can lead to patients’ positive outcomes after stroke.</p><p>This study was registered on ClinicalTrials.gov with the identifier NCT04835363.</p></div>