NCT03864484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

March 2, 2019

Last Update Submit

August 31, 2020

Conditions

Post-stroke Depression

Outcome Measures

Primary Outcomes (1)

  • Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.

    Change from Baseline CES-D at 5 weeks

Secondary Outcomes (4)

  • 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.

    The period from the start of the intervention to 5 weeks

Study Arms (2)

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.

Device: iPad Application + Usual Rehabilitation

Usual rehabilitation

ACTIVE COMPARATOR

The control group receives usual rehabilitation.

Behavioral: Usual rehabilitation

Interventions

iPad Application + Usual RehabilitationDEVICE

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.

iPad Application + Usual Rehabilitation
Usual rehabilitationBEHAVIORAL

The control group receives usual rehabilitation.

Usual rehabilitation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurashiki Heisei Hospital

Kurashiki, Okayama-ken, 710-0826, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34456565DERIVED

Study Officials

  • Kazuki Hirao, PhD

    Kibi International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiroyuki Uchida

CONTACT

+81-86-427-1111hiroyukiuchida02@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 2, 2019

First Posted

March 6, 2019

Study Start

May 7, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)