UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052087 |
|---|---|
| Receipt number | R000059344 |
| Scientific Title | Investigating the Relationship Between Various Impairments and Disabilities with Brain Lesions |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/10/05 11:58:57 |
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Basic information
Public title
Investigating the Relationship Between Various Impairments and Disabilities with Brain Lesions
Acronym
Investigating the Relationship Between Various Impairments and Disabilities with Brain Lesions
Scientific Title
Investigating the Relationship Between Various Impairments and Disabilities with Brain Lesions
Scientific Title:Acronym
Investigating the Relationship Between Various Impairments and Disabilities with Brain Lesions
Region
| Japan |
Condition
Condition
cerebral infarction,intracerebral hemorrhage
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify brain regions associated with the initial and final values of various rehabilitation assessments and the extent of improvement. The purpose of this study is to identify brain regions that are associated with functional disability and performance loss, and to investigate the degree of damage to nerve fiber bundles and whole brain white matter by using diffusion tensor imaging.
The significance of this study is that once the relationship between lesions and functional impairment and loss of ability is clearly elucidated, brain imaging information can be used in combination with conventional evaluation to accurately assess the severity of the disease and estimate prognosis with high accuracy, and to provide more appropriate rehabilitation care to patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fugi meyer assessment,glasgow come scale,berg balance scale,10m walk test,timed up and go test,6minute walk test,trunk control test,functional independence meausure,mini mental state examination,vitality index,scale for contraversive pushing,fractional anisotropy,mean diffusivity
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were hospitalized with cerebrovascular disease (cerebral infarction/cerebral hemorrhage) at our hospital between August 1, 2021 and September 30, 2023 and were prescribed physical therapy, and patients who were hospitalized for cerebrovascular disease (cerebral infarction or cerebral hemorrhage) and prescribed physiotherapy from March 2025 to March 2025 who gave consent for this study (for additional DTI imaging).
Key exclusion criteria
Recurrent cerebrovascular disease, other serious complications such as fractures, death.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Sato |
Organization
Minami tohoku fukushima hospital
Division name
rehabilitation
Zip code
960-2102
Address
3-1-13 Arai Kita, Fukushima City, Fukushima Prefecture
TEL
024-593-5100
poosannpyonnko88@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sato |
Organization
Minami tohoku fukushima hospital
Division name
rehabilitation
Zip code
960-2102
Address
3-1-13 Arai Kita, Fukushima City, Fukushima Prefecture
TEL
024-593-5100
Homepage URL
poosannpyonnko88@yahoo.co.jp
Sponsor or person
Institute
Minami tohoku fukushima hospital
Institute
Department
Personal name
Ryo Sato
Funding Source
Organization
Minami tohoku fukushima hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Minami tohoku fukushima hospital
Address
3-1-13 Arai Kita, Fukushima City, Fukushima Prefecture
Tel
024-593-5100
poosannpyonnko88@yahoo.co.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
| 2023 | Year | 09 | Month | 01 | 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
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Brain imaging is used for the purpose of medical treatment of first stroke patients admitted to our hospital. Using various brain images such as T1-weighted, T2-weighted, T2FLAIR, and diffusion-weighted images taken for the purpose of medical treatment, lesions are delineated using image analysis software such as MRIcron and ITKsnap, and the delineated lesions are analyzed using analysis software such as statistical parametric The mapped lesions are then spatially standardized using analysis software such as statistical parametric mapping (SPM) and FMRIB Software Library (FLS), and the voxel based lesion symptom mapping is an analysis method that applies support vector regression analysis technology based on machine learning theory. Support vector regression based multivariate lesion-symptom mapping (SVR-LSM) is performed. The analysis items include routine assessments usually performed in rehabilitation such as Fugl meyer assessment (FMA), Glasgow Coma Scale (GCS), Berg balance scale (BBS), 10m walking speed, Timed up and go test ( TUG), 6-meter walk test, Trunk Control Test (TCT), Functional Independence Meausure (FIM), Mini Mental State Examination (MMSE), Vitality index (VI), Scale for Contraversive Pushing (SCP), and others. Scores on these assessment indices and associated foci will be investigated using the SVR-LSM.
In addition, DTI will be taken during brain imaging of first stroke patients admitted to our hospital, and various nerve fiber bundles will be depicted using analysis software such as DSIstudio and FSL to verify their relationship to the aforementioned evaluation and to improvement. TBSS and structural connectivity analysis will also be performed to investigate relevant regions in an exploratory manner in the neurowhite matter of the whole brain.In addition, we will investigate the relationship between the need for orthotic prescriptions, the final level of walking independence, and the need for aids for walking.
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059344
