UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052721 |
|---|---|
| Receipt number | R000060153 |
| Scientific Title | Relationship between the brain activity during walking and kinematic indicator in patients with stroke who executive dysfunction |
| Date of disclosure of the study information | 2023/11/08 |
| Last modified on | 2023/11/17 15:59:57 |
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Basic information
Public title
Relationship between the brain activity during walking and kinematic indicator in patients with stroke who executive dysfunction
Acronym
Relationship between the brain activity during walking and kinematic indicator in patients with stroke who executive dysfunction
Scientific Title
Relationship between the brain activity during walking and kinematic indicator in patients with stroke who executive dysfunction
Scientific Title:Acronym
Relationship between the brain activity during walking and kinematic indicator in patients with stroke who executive dysfunction
Region
| Japan |
Condition
Condition
Patients with stroke
Elderly people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine changes in brain activity and kinematic indices during dual task walking in stroke patients with executive dysfunction compared to stroke patients without executive dysfunction and older adults.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the recovery process of executive dysfunction in patients with stoke.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Walking time and brain activity
Dual task walking time and brain activity
Walking variation
Frontal assessment battery
Stroop Color Word Test
Trail Making Test
Key secondary outcomes
Brunnstrom Recovery Stage
Stroke Impairment Assessment Set
Berg Balance Scale
Functional Independent Measure
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participant can walking
Participant can the assessment of executive function
Key exclusion criteria
Stroke
Those with a diagnosis of hemispatial neglect or sensory aphasia (difficulty understanding) or both
Patients with severe higher brain dysfunction whose executive function impairment is difficult to assess
Patients with dementia
Those with orthopedic diseases for which surgery is being performed
Patyients with a diagnosis of aphasia
Elderly persons
Those who have been diagnosed with dementia by a physician.
Those who have undergone surgery for orthopedic disease in the past
Those who have been diagnosed with stroke in the past.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
0338191211
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
Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
0338191211
Homepage URL
k.sakai@tmu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Reiwa Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
Tel
0338191211
k.sakai@tmu.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
令和リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 08 | 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
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | 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
Observational study
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060153
| Research Plan | |
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| 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 |
