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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047668
Receipt No. 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

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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
Email 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
Email kinoshita.shiori.0906@gmail.com

Sponsor
Institute Kio university
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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