iPad Application-based Intervention for Post-stroke Depression

Not Applicable

• Conditions: Post-stroke Depression
• Interventions: Device: iPad Application + Usual Rehabilitation; Behavioral: Usual rehabilitation

• Registration Number: NCT03864484
• Lead Sponsor: Kibi International University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-02
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Study Start: 2019-05-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPad Application + Usual Rehabilitation	iPad Application + Usual Rehabilitation	The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli.
Usual rehabilitation	Usual rehabilitation	The control group receives usual rehabilitation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Activities of daily living as measured by Functional Independence Measure (FIM).	Change from Baseline FIM 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.
Dynamic standing balance as measured by Functional Reach Test (FRT).	Change from Baseline FRT at 5 weeks
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

Trial Locations

Locations (1)

Kurashiki Heisei Hospital; 🇯🇵 Kurashiki, Okayama, Japan