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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPad Application + Usual Rehabilitation | Experimental | The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli. |
|
| Usual rehabilitation | Active Comparator | The control group receives usual rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPad Application + Usual Rehabilitation | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroyuki Uchida | Contact | +81-86-427-1111 | hiroyukiuchida02@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kazuki Hirao, PhD | Kibi International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurashiki Heisei Hospital | Recruiting | Kurashiki | Okayama-ken | 710-0826 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34456565 | Derived | Ejiri H, Uchida H, Tsuchiya K, Fujiwara K, Kikuchi S, Hirao K. Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2021 Aug 20;17:2739-2748. doi: 10.2147/NDT.S323126. eCollection 2021. |
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| Usual rehabilitation | Behavioral | The control group receives usual rehabilitation. |
|
| 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 |