UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053805 |
|---|---|
| Receipt number | R000061413 |
| Scientific Title | Relationship between the executive dysfunction and motor imagery in patients with stroke |
| Date of disclosure of the study information | 2024/03/11 |
| Last modified on | 2024/03/08 12:22:40 |
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Basic information
Public title
Relationship between the executive dysfunction and motor imagery in patients with stroke
Acronym
Relationship between the executive dysfunction and motor imagery in patients with stroke
Scientific Title
Relationship between the executive dysfunction and motor imagery in patients with stroke
Scientific Title:Acronym
Executive dysfunction and motor imagery in stroke
Region
| Japan |
Condition
Condition
Patients with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate relationship between the executive function and motor imagery in patients with stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor imagery ability (Imagined Timed Up and Go Test[TUGT], Imagined peg time)
Trail Making Test (TMT)
Frontal Assessment Battery
Key secondary outcomes
Trunk Control Test (TCT)
Scale for Contraversive Pushing (SCP)
Digit Span test
Hospital Anxiety and Depression Scale (HADS)
Dimensional Apathy Scale (DAS)
Mini Mental State Examination (MMSE)
TUGT
Peg time
Center of pressure task
10m walking test
Wisconsin gait scale
F wave
Sequence task
Fugl-meyer assessment (FMA)
Brunnstrom recovery scale
stroke impairment assessment set (SIAS) sensory part
Berg Balance Scale (BBS)
Functional independent measure (FIM)
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First stroke
Rehabilitation prescription is issued
Not participating in other intervention studies
Key exclusion criteria
Diagnosed with dementia
Difficulty in understanding instructions
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Department of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
k.sakai@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Department of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
k.sakai@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Univerisity
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
Tokyo International University Medical Research Ethics Review Committee
Address
1-13-1, Matobakita, Kawagoe, Saitama
Tel
050-3536-0169
tkawasa@tiu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23-10
Org. issuing International ID_1
Tokyo International University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
令和リハビリテーション病院 (千葉県)
東京さくら病院（東京都）
松戸リハビリテーション病院 (千葉県)
京都田辺記念病院 (京都府)
喜馬病院 (大阪府)
森山脳神経センター病院 (東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 11 | 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
| 2023 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2024 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061413
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| Registered date | File name |
| Research case data | |
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