We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone. The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
The experimental group receives usual rehabilitation. In addition, the experimental group will watch movies using the iPad application for 3 minutes, once daily for 5 weeks.
The control group receives usual rehabilitation.
Kurashiki Heisei Hospital
Kurashiki, Okayama-ken, Japan
RECRUITINGDepression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Time frame: Change from Baseline CES-D at 5 weeks
Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).
Time frame: Change from Baseline SF-36 at 5 weeks
Activities of daily living as measured by Functional Independence Measure (FIM).
Time frame: Change from Baseline FIM at 5 weeks
Dynamic standing balance as measured by Functional Reach Test (FRT).
Time frame: Change from Baseline FRT at 5 weeks
Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.
Adverse events, whether or not considered causally related to the study intervention, include death and life-threatening illness or injury requiring prolonged hospitalization or resulting in persistent disability.
Time frame: The period from the start of the intervention to 5 weeks
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