UMIN-CTR Clinical Trial

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
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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
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Results Delayed
Results Delay Reason
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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
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Research case data
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