UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050342 |
|---|---|
| Receipt number | R000057321 |
| Scientific Title | The effects of distance and different conditions on eye movements of patients with unilateral spatial neglect during visual search |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2025/02/16 11:06:48 |
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Basic information
Public title
The effects of distance and different conditions on eye movements of patients with unilateral spatial neglect during visual search
Acronym
The effects of distance and different conditions on eye movements of patients with unilateral spatial neglect during visual search
Scientific Title
The effects of distance and different conditions on eye movements of patients with unilateral spatial neglect during visual search
Scientific Title:Acronym
The effects of distance and different conditions on eye movements of patients with unilateral spatial neglect during visual search
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify the effects of distance ( near space and far space) and different conditions (free viewing of various images) on eye movements of patients with unilateral spatial neglect during visual search.
Basic objectives2
Others
Basic objectives -Others
evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) number of fixation count
2) total distance of gaze trajectory
3) gaze onset
4) gaze velocity (leftward / rightward)
5) gaze shift (initial / search)
6) horizontal gaze distribution
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
group with unilateral spatial neglect
Interventions/Control_2
group without unilateral spatial neglect (right hemisphere damaged)
Interventions/Control_3
control subjects
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) stroke patient by right hemisphere damaged (initial)
2) left unilateral spatial neglect patient (Behavioural Inattention Test conventional score 131 or less)
3) sitting ability is maintained
Key exclusion criteria
1) bilateral lesions
2) a history of major psychiatric or neurological disorders other than stroke
3) homonymous hemianopsia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tamura |
Organization
Okayama Healthcare Professional University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
700-0913
Address
3-2-18 Daiku, Kita-ku, Okayama, Okayama
TEL
086-233-8020
tamura@opu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tamura |
Organization
Okayama Healthcare Professional University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
700-0913
Address
3-2-18 Daiku, Kita-ku, Okayama, Okayama
TEL
086-233-8020
Homepage URL
tamura@opu.ac.jp
Sponsor or person
Institute
Kishiwada Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kishiwada Rehabilitation Hospital
Address
2-8-10 Kamimatsu-cho, Kishiwada, Osaka, 596-0827
Tel
072-426-7777
t_fuchigami@eishinkaihsp.or.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
| 2023 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057321
