iPad Application-based Intervention for Post-stroke Depression

August 31, 2020 updated by: Kazuki Hirao, PhD, OT, Kibi International University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Okayama
      • Kurashiki, Okayama, Japan, 710-0826

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iPad Application + Usual Rehabilitation
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
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.
Active Comparator: Usual rehabilitation
The control group receives usual rehabilitation.
Behavioral: Usual rehabilitation
The control group receives usual rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Time Frame: Change from Baseline CES-D at 5 weeks
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).
Time Frame: Change from Baseline SF-36 at 5 weeks
Change from Baseline SF-36 at 5 weeks
Activities of daily living as measured by Functional Independence Measure (FIM).
Time Frame: Change from Baseline FIM at 5 weeks
Change from Baseline FIM at 5 weeks
Dynamic standing balance as measured by Functional Reach Test (FRT).
Time Frame: Change from Baseline FRT at 5 weeks
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.
Time Frame: 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.
The period from the start of the intervention to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kibi International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2019

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

March 2, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H30-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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