iPad Application-based Intervention for Post-stroke Depression

Study Overview
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Brief Summary
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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.

Official Title
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An iPad Application-based Intervention for Improving Post-stroke Depression Symptoms: A Pilot Randomized Controlled Trial

Conditions
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Post-stroke Depression

Intervention / Treatment
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* Device: iPad Application + Usual Rehabilitation
* Behavioral: Usual rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPad Application + Usual Rehabilitation<br>The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli. | Device: iPad Application + Usual Rehabilitation<br>* 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.<br>|
| Active Comparator: Usual rehabilitation<br>The control group receives usual rehabilitation. | Behavioral: Usual rehabilitation<br>* The control group receives usual rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | The period from the start of the intervention to 5 weeks |