UMIN-CTR Clinical Trial

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
Institute	Akita university graduate school of health sciences
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043344