NCT03546218

Brief Summary

The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

8 days

First QC Date

May 22, 2018

Last Update Submit

July 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Multi-Directional Reach Test

    The limits of stability during multi-direction reach operation in standing position

    Baseline and immediately after the intervention protocol

Study Arms (2)

Smartphone Application (SPSRS)

EXPERIMENTAL

Participants watch motion picture using an application that displays positive-word stimuli.

Device: Smartphone Application (SPSRS)

Smartphone Application (YouTube)

ACTIVE COMPARATOR

Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.

Device: Smartphone Application (YouTube)

Interventions

Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds. The participants watch 3-minute motion picture displaying positive-word stimuli.

Smartphone Application (SPSRS)

Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.

Smartphone Application (YouTube)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers between 18 and 24 years of age
  • Males and Females

You may not qualify if:

  • Person with physical disability that is enough to interfere with daily life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kibi International University

Takahashi, Okayama-ken, Japan

Location

Related Publications (1)

  • Azukizawa K, Hirose K, Morigami Y, Higashi N, Uchida H, Hirao K. Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial. Ann Med. 2021 Dec;53(1):1402-1409. doi: 10.1080/07853890.2021.1968483.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 6, 2018

Study Start

June 6, 2018

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations