UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056910 |
|---|---|
| Receipt number | R000065041 |
| Scientific Title | The effects of vision and attention during obstacle avoidance in individuals with stroke |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/02/04 11:08:29 |
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Basic information
Public title
The effects of vision and attention during obstacle avoidance in individuals with stroke
Acronym
The effects of vision and attention during obstacle avoidance in individuals with stroke
Scientific Title
The effects of vision and attention during obstacle avoidance in individuals with stroke
Scientific Title:Acronym
The effects of vision and attention during obstacle avoidance 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 clarify the influence of visual field and attention on the rotation of the body of individuals with stroke and to consider approaches to prevent falls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contact with obstacles, rotation angle, margin to obstacles
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)
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 (MMS
Target sample size
17
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, Faculty of Health Care Sciences
Zip code
2600801
Address
645-1 Nitona-cho, Chiba Chuo-ku, Chiba, Japan.
TEL
0433052132
mutyon88@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Chiba Prefectural University of Health Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Health Care Sciences
Zip code
2600801
Address
645-1 Nitona-cho, Chiba Chuo-ku, Chiba, Japan.
TEL
0433052132
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 Higashi-cho Kamogawa Chiba, Japan
Tel
0470922211
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
| 2025 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
17
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Participants were asked to pass through a opening created by two screens 4m ahead of them without colliding with it. The experiment was conducted under conditions in which participants used glasses that restricted their downward field of vision, under a subtraction condition, or under a control condition with no restrictions. A total of 18 trials were conducted, with three for the paretic and the non-paretic side entry.
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065041
