Post-stroke Depression
Conditions
Brief summary
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.
Interventions
DEVICEiPad Application + Usual Rehabilitation
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.
BEHAVIORALUsual rehabilitation
The control group receives usual rehabilitation.
Sponsors
Kibi International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 40 years and older * Males and females * Center for Epidemiologic Studies Depression Scale score ≥16 * Mini Mental State Examination score ≥ 24 * First stroke * Native language is Japanese * Written informed consent prior to participation
Exclusion criteria
* Major depressive disorder before onset of stroke * Bilateral hemiplegia * Vision or hearing deficits that negatively impact everyday life * Severe aphasia * Severe unilateral spatial neglect * Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy * Current life-threatening severe organ failure, musculoskeletal disorders, or cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score. | Change from Baseline CES-D at 5 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36). | Change from Baseline SF-36 at 5 weeks | — |
| Activities of daily living as measured by Functional Independence Measure (FIM). | Change from Baseline FIM at 5 weeks | — |
| Dynamic standing balance as measured by Functional Reach Test (FRT). | 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. | The period from the start of the intervention to 5 weeks | 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. |
Countries
Japan
Contacts
Primary ContactHiroyuki Uchida
Outcome results
None listed