UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038021
Receipt number R000043344
Scientific Title Influences of smartphone use while walking on foot pressure for healthy adults open non-randomized single trial.
Date of disclosure of the study information 2020/01/01
Last modified on 2020/03/20 20:39:50

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Basic information

Public title

Influences of smartphone use while walking on foot pressure for healthy adults open non-randomized single trial.

Acronym

Influences of smartphone use while walking on foot pressure for healthy adults single trial.

Scientific Title

Influences of smartphone use while walking on foot pressure for healthy adults open non-randomized single trial.

Scientific Title:Acronym

Influences of smartphone use while walking on foot pressure for healthy adults single trial.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To discover changes in the foot pressure pattern when smartphone use while walking and alert in activities of daily living

Basic objectives2

Others

Basic objectives -Others

Kinematics

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Percentage of the anteroposterior length og the center of pressure path to the foot length(%Long)
A scheme of the five areas(heel,central,metatarsal,hallux,and lateral toes parts)for which partical pressure as a percentage of body weight(%PFP)

Key secondary outcomes

walking speed
step lengths
durations of the stance
durations of the swing
coefficient of variation


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Individual subjects walk on a flat 14-m walking course at a comfortable speed and are 2 trials

Interventions/Control_2

Individual subjects walk on a flat 14-m walking course at a comfortable speed while looking smartphone screen and are 2 trials

Interventions/Control_3

Individual subjects walk on a flat 14-m walking course at a comfortable speed while using SNS with smartphone and are 2 trials

Interventions/Control_4

Individual subjects walk on a flat 14-m walking course at a comfortable speed while using cognitive application(like stroop-test) with smartphone and are 2 trials

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Over twenty years old
Use smartphone on a daily basis

Key exclusion criteria

Have visual impairment to affect the use smartphone
Have any neurological and/or musculoskeletal disorders that will interfere with gait

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Ryohei
Middle name
Last name Kondo

Organization

Akita university graduate school of health sciences

Division name

Department of physical therapy

Zip code

010-8543

Address

1 Chome-1-1 Hondo,akita city,akita prefecture

TEL

018-884-6500

Email

m4818008@s.akita-u.ac.jp


Public contact

Name of contact person

1st name Ryohei
Middle name
Last name Kondo

Organization

Akita university graduate school of health sciences

Division name

Department of physical therapy

Zip code

010-8543

Address

1 Chome-1-1 Hondo,akita city,akita prefecture

TEL

018-884-6500

Homepage URL


Email

m4818008@s.akita-u.ac.jp


Sponsor or person

Institute

Akita university graduate school of health sciences

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Akita university graduate school of health sciences

Address

1 Chome-1-1 Hondo,akita city,akita prefecture

Tel

018-884-6500

Email

sryohei@outlook.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 10 Month 01 Day

Date of IRB

2019 Year 09 Month 24 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2019 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 17 Day

Last modified on

2020 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043344


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name