UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041955 |
|---|---|
| Receipt number | R000047882 |
| Scientific Title | Characteristics of extrapersonal neglect in patients with left unilateral spatial neglect |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2023/02/12 17:18:25 |
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Basic information
Public title
Characteristics of extrapersonal neglect in patients with left unilateral spatial neglect
Acronym
Characteristics of extrapersonal neglect in patients with left unilateral spatial neglect
Scientific Title
Characteristics of extrapersonal neglect in patients with left unilateral spatial neglect
Scientific Title:Acronym
Characteristics of extrapersonal neglect in patients with left unilateral spatial neglect
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 validity of assessment for extrapersonal neglect during walking using a virtual reality task and a treadmill.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measurement item of the VR task
(1) total score
(2)number of errors on the right or left side
(3) mean neck rotation angle
(4) maximum neck rotation angle on the right or left side
(5) total time of neck rotation to the right or left side
(6) left-right ratio
(7) time required to complete the task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
unilateral spatial neglect group
Interventions/Control_2
elderly healthy group
Interventions/Control_3
young healthy group
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)ability to walk for the duration of the virtual reality task
(2)no apparent cognitive impairment (Mini-Mental State Examination (MMSE) score of more than 23 points)
(3) no apparent speech, hearing, or psychological disorder
(4) normal neck rotation motion
Key exclusion criteria
(1)disability to walk for the duration of the virtual reality task
(2) apparent cognitive impairment (Mini-Mental State Examination (MMSE) score of less than 23 points)
(3) apparent speech, hearing, or psychological disorder
(4) abnormal neck rotation motion
Target sample size
30
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
Graduate School of Health Sciences, Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
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
Graduate School of Health Sciences, Kobe University
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Hyogo, 654-0142
Tel
078-796-4502
syomu2@ams.kobe-u.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
| 2020 | Year | 09 | Month | 30 | 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
11
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
now writing
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
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
