UMIN-CTR Clinical Trial

Basic information
Public title	Gait analysis of phoria patients
Acronym	Gait analysis of phoria patients
Scientific Title	Effects of phoria on posture control during walking
Scientific Title:Acronym	Effects of phoria during walking
Region	Japan

Condition
Condition	phoria
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effects of phoria on postural control during walking.
Basic objectives2	Others
Basic objectives -Others	Kinematic and kinetic analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle activity on lower extremity Acceleration on trunk Center of pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Eye glasses to correct phoria
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	phoria patients
Key exclusion criteria	Lower extremity impairment that disturb walking Those that correct vision by means of eyeglasses
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kanda Middle name Last name Yasushi
Organization	Kio University
Division name	Graduate School of Health Sciences
Zip code	6350832
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745541601
Email	f2958926@kio.ac.jp

Public contact
Name of contact person	1st name Kanda Middle name Last name Yasushi
Organization	Kio University
Division name	Graduate School of Health Sciences
Zip code	6350832
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745541601
Homepage URL
Email	f2958926@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kio University
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel	0745541601
Email	soumu@kio.ac.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	2022 Year 04 Month 08 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
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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date	2022 Year 04 Month 09 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 06 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054083