iPad Application-based Intervention for Post-stroke Depression

Post-stroke Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864484
• Other study ID #: H30-038
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: August 2020
• Source: Kibi International University
• Contact: Hiroyuki Uchida
• Phone: +81-86-427-1111
• Email: hiroyukiuchida02[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

Device:
• iPad 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.

Behavioral:
• Usual rehabilitation
The control group receives usual rehabilitation.

Locations

Country	Name	City	State
Japan	Kurashiki Heisei Hospital	Kurashiki	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Kibi International University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.		Change from Baseline CES-D at 5 weeks
Secondary	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
Secondary	Activities of daily living as measured by Functional Independence Measure (FIM).		Change from Baseline FIM at 5 weeks
Secondary	Dynamic standing balance as measured by Functional Reach Test (FRT).		Change from Baseline FRT at 5 weeks
Secondary	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