UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023915 |
|---|---|
| Receipt number | R000027395 |
| Scientific Title | A study of attention bias modification training in stroke patients. |
| Date of disclosure of the study information | 2016/09/03 |
| Last modified on | 2023/09/08 22:01:43 |
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Basic information
Public title
A study of attention bias modification training in stroke patients.
Acronym
A study of attention bias modification training in stroke patients.
Scientific Title
A study of attention bias modification training in stroke patients.
Scientific Title:Acronym
A study of attention bias modification training in stroke patients.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study develops a method for measuring and intervening attention bias in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main outcome is attention bias measured by developed app before and after 4 weeks of intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Attention bias modification training for stroke patients. Intervention method is dot probe task or cue target task. Stimuli is facial stimulation or word stimulation. This intervention is carried out for 4 weeks.
Interventions/Control_2
Attention bias modification placebo training for stroke patients. Intervention method is dot probe task or cue target task. Stimuli is facial stimulation or word stimulation. This intervention is carried out for 4 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients in convalescent hospital.
Patients prescribed occupational therapy.
Stroke patients were required in Mini-Mental State Examination score over 24 points.
Key exclusion criteria
Stroke patients have communication problems.
Stroke patients are receiving antidepressants.
Stroke patients did not get consent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toyohiro |
| Middle name | |
| Last name | Hamaguchi |
Organization
Saitama Prefectural University
Division name
Department of Occupational Therapy
Zip code
343-8540
Address
820 Sannomiya, Koshigaya City, Saitama
TEL
048-973-4125
hamaguchi-toyohiro@spu.ac.jp
Public contact
Name of contact person
| 1st name | Toyohiro |
| Middle name | |
| Last name | Hamaguchi |
Organization
Saitama Prefectural University
Division name
Department of Occupational Therapy
Zip code
343-8540
Address
820 Sannomiya, Koshigaya City, Saitama
TEL
048-973-4125
Homepage URL
hamaguchi-toyohiro@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University, Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Ethics Committee of Saitama Prefectural University
Address
820 Sannomiya, Koshigaya city, Saitama 343-8540, Japan
Tel
048-971-0500
rinri@spu.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
新座病院（埼玉県）
戸田中央リハビリテーション病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027395
| 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 |
