OBJECTIVE: To compare occupation-based and impairment-based approaches in occupational therapy and determine the feasibility of patient recruitment and retention. DESIGN: A multicenter, randomized, controlled pilot trial with a single blind assessor. SETTING: Ten subacute rehabilitation units in Japan. PARTICIPANTS: Fifty-four patients with subacute stroke. INTERVENTIONS: The experimental group used the iPad application, Aid for Decision-making in Occupation Choice, to establish occupation-based goals, and evaluation and intervention were conducted mainly through real occupations. The control group was evaluated according to patients' generic abilities and activities of daily living (ADL), and the intervention mainly involved the impairment-based approach. MAIN OUTCOME MEASURES: Short Form-36, Functional Independence Measure, Brunnstrom recovery stages, The Client Satisfaction Questionnaire, and length of hospital stay. RESULTS: Of the 1465 potential participants, 54 (3%) subacute stroke patients were enrolled over 16 months and 68% (n = 36) were retained to the 2-month assessment: experimental group (n = 16); control group (n = 21). Although there was no significant intergroup difference for any outcomes, the experimental group had a small effect size advantage on the Short Form-36 "General health" (d = 0.42) and "Role emotional" (d = 0.43) subscales relative to the control group. A sample of 118 subacute stroke patients per group would be required for a lager study. CONCLUSIONS: Results suggest that the occupation-based approach has more potential to improve "General health" and "Role emotional" scores on the Short Form-36 than the impairment-based approach. Further investigation of study protocol with interventions and recruiting is needed prior to a larger trial.

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