UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061380 |
|---|---|
| Receipt number | R000070231 |
| Scientific Title | The effect of visual attention training on improving ADL ability in patients with subacute stroke: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2026/04/26 |
| Last modified on | 2026/04/26 18:29:24 |
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Basic information
Public title
A study investigating whether training to improve visual attention can help improve to activities of daily living in patients with subacute stroke.
Acronym
Stroke attention training research
Scientific Title
The effect of visual attention training on improving ADL ability in patients with subacute stroke: A pilot randomized controlled trial
Scientific Title:Acronym
VAT-ADL Trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of visual attention training on improving ADL abilities compared to auditory attention training in patients with subacute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure (FIM)(pre/post/at discharge from the hospital)
Key secondary outcomes
Trail Making Test-Japanese (TMT-J) Part A,Part B
Behavioral Assessment of Attentional Disturbance (BAAD)
Attention (Creact Co., Ltd.) Evaluation tool
Paced Auditory Serial Addition Task (PASAT)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual attention function training. In addition to standard rehabilitation interventions, interventions lasting approximately 20 minutes each will be conducted 5 days a week for 3 weeks outside of clinical time. The rehabilitation tool (touch panel mode) from Attention (Creact Co., Ltd.) was used. The sequence of passive element order to random, active element deletion to coloring to deletion noise to coloring noise was repeated twice. Evaluations will be conducted before and after the intervention and at discharge.
Interventions/Control_2
Auditory attention function training.
In addition to standard rehabilitation interventions, interventions lasting approximately 20 minutes each will be conducted 5 days a week for 3 weeks outside of clinical time. The Paced Auditory Serial Addition Test (PASAT), included in the Clinical Assessment for Attention - Revised (CAT-R), was used.
The process of practicing under the 2-second condition followed by the actual trial, and then practicing under the 1-second condition followed by the actual trial, will be repeated twice in sequence. Evaluations will be conducted before and after the intervention, and at discharge.
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
Inclusion criteria were as follows: patients with a first-ever stroke (cerebral infarction or cerebral hemorrhage); those who were more than 3 months post-stroke; individuals who were independent in activities of daily living prior to stroke onset; and those for whom consent was obtained from the attending physician.
Key exclusion criteria
Exclusion criteria were as follows: patients with subarachnoid hemorrhage; those aged less than 20 or greater than or equal to 90 years; those with scattered cerebral infarctions; those with infratentorial lesions; patients with clear visual or hearing impairments at the time of recruitment; those with evident aphasia at recruitment; those who scored less than 24 on the MMSE-J at the most recent evaluation at recruitment; those who scored less than 3 on the SIAS visuospatial perception item at the most recent evaluation at recruitment; those with a motor FIM score greater than or equal to 78 or less than 39 at recruitment; those who required greater than or equal to 300 seconds to complete the TMT-J Part A during the pre-evaluation; those hospitalized for clinical trials or for post-stroke sequelae; those participating in other intervention studies; those who wished to resume driving after stroke and were undergoing evaluation; and those who did not provide consent.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Nambu |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
2750026
Address
4-1-1 Yatsu, Narashino City, Chiba, Japan.
TEL
0474539000
mihofh425@gmail.com
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Nambu |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
2750026
Address
4-1-1 Yatsu, Narashino City, Chiba, Japan.
TEL
0474539000
Homepage URL
https://wanreha.net/patient-rights/clinical-research/
mihofh425@gmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Miho Nambu
Funding Source
Organization
Tokyo Bay Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
GRADUATE SCHOOL OF HUMAN SCIENCES, UNIVERSITY OF TSUKUBA
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Bay Area Rehabilitation Hospital Ethics Review Committee
Address
4-1-1 Yatsu, Narashino City, Chiba, 275-0026, Japan.
Tel
0474539000
shinsakai@wanreha.net
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
東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070231
