UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of relationship between eye movements and postural control as well as higher brain function in stroke patients
Acronym	Relationship between eye movements and postural control as well as higher brain function
Scientific Title	Analysis of relationship between eye movements and postural control as well as higher brain function in stroke patients
Scientific Title:Acronym	Relationship between eye movements and postural control as well as higher brain function
Region	Japan

Condition
Condition	Cerebrovascular disease
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of eye movements on rehabilitative task in stroke patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rehabilitative task: 1) eye movements; temporospatial gaze area mapping , 2)Higher brain disorders; Clinical assessment for unilateral spatial neglect, attention task, 3) vertical orientation disorders; subjective visual vertical, postural control task Evaluation schedule: Before intervention and after 5 days intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The 1st week: Standard exercise with gaze point feedback (20 minutes once a day for 5 consecutive days) The 2nd week: Standard exercise without gaze point feedback (20 minutes once a day for 5 consecutive days)
Interventions/Control_2	The 1st week: Standard exercise without gaze point feedback (20 minutes once a day for 5 consecutive days) The 2nd week: Standard exercise with gaze point feedback (20 minutes once a day for 5 consecutive days)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted for cerebrovascular disease treatments within 2 months and required rehabilitative treatments to higher brain dysfunction such as unilateral spatial neglect and inattention, motor palsy, or disturbed postural control.
Key exclusion criteria	Patients who cannot understand instructions due to consciousness disorder, aphasia, or dementia History of other brain diseases
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kimitaka Middle name Last name Hase
Organization	Kansai Medical University Hospital
Division name	Department of Rehabilitation Medicine
Zip code	573-1191
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Email	hasekim@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Kimitaka Middle name Last name Hase
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of Rehabilitation Medicine
Zip code	573-1191
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Homepage URL
Email	hasekim@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hospital
Institute
Department

Funding Source
Organization	Kansai Medical University Hospital
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	Ethic Committee of Kansai Medical University
Address	2-5-1 Shin-Machi, Hirakata, 573-1191, Osaka, Japan
Tel	072-804-2294
Email	kenkyu@hirakata.kmu.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	2016 Year 03 Month 01 Day

Related information
URL releasing protocol	https://www.sciencedirect.com/science/article/abs/pii/S0168010219305668
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/abs/pii/S0168010219305668
Number of participants that the trial has enrolled	43
Results	Visual vertical (VV), visually perceived direction of gravity, is widely measured to assess the vestibular function and visuospatial cognition. VV has been assessed by comparing orientation and variability of measured values separately between subject groups. However, changes in orientation and variability often differ in patients with unilateral spatial neglect (USN). Here, we developed a novel classification of VV that combines orientation and variability and characterized the effects of USN on VV.
Results date posted	2021 Year 03 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with a first episode of hemorrhagic or ischemic hemispheric stroke
Participant flow	In a dark room, a line tilted 30 degree to the left or right from vertical (0 degree) was presented. When subjects judged the line to be vertical, they verbally instructed the operator to stop the rotating line. Subjects performed 10 trials consisting of five trials starting tilted to the right and five trials starting tilted to the left, which were presented in a random order.
Adverse events	None
Outcome measures	The deviation of the subjectively-perceived vertical from the true vertical (visual vertical, VV)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 14 Day
Date of IRB	2015 Year 10 Month 14 Day
Anticipated trial start date	2015 Year 10 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 01 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024540