UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021273 |
|---|---|
| Receipt number | R000024540 |
| Scientific Title | Analysis of relationship between eye movements and postural control as well as higher brain function in stroke patients |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2021/03/11 21:24:09 |
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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
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
hasekim@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024540
