UMIN-CTR Clinical Trial

Basic information
Public title	Development of a predictive model for patients with stroke
Acronym	Development of a predictive model for patients with stroke
Scientific Title	Development of a predictive model for patients with stroke
Scientific Title:Acronym	Development of a predictive model for patients with stroke
Region	Japan

Condition
Condition	patients with stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct a comprehensive prospective study of motor and higher brain functions affecting walking independence in stroke patients.
Basic objectives2	Others
Basic objectives -Others	recurrence risk
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of days to acquire independent walking
Key secondary outcomes	ADL at discharge Sarcopenia and Frailty Amount of change in higher brain function at discharge Change in physical function at discharge Physical activity at admission All-cause mortality

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with stroke who visited Kitasato University Hospital
Key exclusion criteria	Subjects who have difficulty communicating due to severe impairment of consciousness Subjects with musculoskeletal or internal diseases that limit activities of daily living
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Tetsuharu Middle name Last name Nakazono
Organization	Kitasato University Hospital
Division name	Department of Rehabilitation
Zip code	252-0375
Address	1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
TEL	0427788413
Email	ptnaka@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Tetsuharu Middle name Last name Nakazono
Organization	Kiatasato University Hospital
Division name	Department of Rehabilitation
Zip code	252-0375
Address	1-15-1, Kitasato, Minamiku, Sagamihara-city, Japan
TEL	0427788413
Homepage URL
Email	ptnaka@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Hospital
Institute
Department

Funding Source
Organization	None
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	Kitasato University Hospital
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Japan
Tel	0427788413
Email	ptnaka@kitasato-u.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	北里大学病院

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 10 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	2021 Year 04 Month 01 Day
Date of IRB	2021 Year 07 Month 16 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The inclusion of subjects and the follow-up period will be extended, if necessary, with the approval of the Ethical Review Committee.

Management information
Registered date	2022 Year 09 Month 10 Day
Last modified on	2022 Year 09 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055687