UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051433 |
|---|---|
| Receipt number | R000058668 |
| Scientific Title | Gaze behavior during body rotation in individuals with stroke. |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/23 16:19:51 |
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Basic information
Public title
Gaze behavior during body rotation in individuals with stroke.
Acronym
Gaze behavior during body rotation in individuals with stroke.
Scientific Title
Gaze behavior during body rotation in individuals with stroke.
Scientific Title:Acronym
Gaze behavior during body rotation in individuals with stroke.
Region
| Japan |
Condition
Condition
individuals with stroke who had hemiplegia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reveal gaze behavior during body rotation of stroke patients and to examine approaches to gaze behavior for fall prevention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gaze fixation position, gaze fixation time, number of gazes
Key secondary outcomes
Mini-Mental State Examination test(MMSE), 10m walking test (10MWT),
Berg Balance Scale (BBS), Activities-specific balance confidence (ABC),
Predicted and actual values of Functional Reach Test(FRT) and Timed up and Go test(TUG)
Accelerometer reading
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants had been walking for at least one month after a first-time stroke and that they were able to walk independently for more than 100 m with or without an assistive device.
Key exclusion criteria
None of the participants had any indications of the following symptoms: (a) neurological, orthopedic, or other disorders that could affect walking, (b) history of visual deficits, (c) visual field deficits and visual-spatial neglect, and (d) a score of less than 24 on the Mini-Mental State Examination (MMSE)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Chiba Prefectural University of Health and Sciences
Division name
Department of Rehabilitation Sciences, Division of Physical Therapy
Zip code
260-0801
Address
645-1 Nitona-cho, Chiba Chuo-ku, Chiba, 260-0801, Japan.
TEL
043-305-2169
mutyon88@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Chiba Prefectural University of Health and Sciences
Division name
Department of Rehabilitation Sciences, Division of Physical Therapy
Zip code
260-0801
Address
645-1 Nitona-cho, Chiba Chuo-ku, Chiba, 260-0801, Japan.
TEL
043-305-2169
Homepage URL
mutyon88@hotmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Daisuke Muroi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kameda medical center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda medical center
Address
929 Higashicho, Kamogawa, Chiba 296-8602, Japan
Tel
04-7092-2211
clinical_research@kameda.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 | 06 | Month | 23 | 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
| 2022 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants wore an eye-mark recorder (EMR-9, Nac Co., Ltd.) and a small accelerometer (AMWS020, ATR-promotions). They are presented with the aperture made of two screens 4m in front of the participants and they perform the walking through the aperture task six times. Then, they perform the timed up-and-go task three times on each side (paretic and non-paretic side).
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058668
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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