UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047668 |
|---|---|
| Receipt number | R000054346 |
| Scientific Title | Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients |
| Date of disclosure of the study information | 2022/05/15 |
| Last modified on | 2022/05/06 16:55:44 |
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Basic information
Public title
Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients
Acronym
Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients
Scientific Title
Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients
Scientific Title:Acronym
Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the brain mechanisms that cause sensory deficit and sense of ownership/agency changes after stroke.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Bedside Quantitative Sensory Testing of after admission to the rehabilitation ward and 1 month, 2 months ,3 months
Key secondary outcomes
Fugl-Meyer Assessment upper/lower limb sensory score, sense of ownership/agency questionnaire of after admission to the rehabilitation ward and 1 month, 2 months ,3 months
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke patients with and without sensory deficit
Key exclusion criteria
Persons with complications of sensory disorders originating from peripheral nerves, such as diabetes mellitus, or from spinal nerve roots, such as spinal canal stenosis
Mini Mental State Examination-J (MMSE-J) <= 23
Patients with aphasia who cannot understand the research or the explanation of the assignment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shiori |
| Middle name | |
| Last name | Kinoshita |
Organization
JCHO Hoshigaoka Medical Center
Division name
Department of Rehabilitation
Zip code
573-8511
Address
4-8-1 Hoshigaoka, Hirakata City, Osaka
TEL
072-840-2641
kinoshita.shiori.0906@gmail.com
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Kinoshita |
Organization
JCHO Hoshigaoka Medical Center
Division name
Department of Rehabilitation
Zip code
573-8511
Address
4-8-1 Hoshigaoka, Hirakata City, Osaka
TEL
072-840-2641
Homepage URL
kinoshita.shiori.0906@gmail.com
Sponsor or person
Institute
Kio university
Institute
Department
Personal name
Funding Source
Organization
Kio university
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
JCHO Hoshigaoka Medical Center
Address
4-8-1 Hoshigaoka, Hirakata City, Osaka
Tel
072-840-2641
kinoshita.shiori.0906@gmail.com
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
| 2022 | Year | 05 | Month | 15 | 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
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cross-sectional study
Recruitment methods: Patients admitted to our hospital's convalescence rehabilitation ward who meet the selection and exclusion criteria are included.
Management information
Registered date
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054346
