UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048903 |
|---|---|
| Receipt number | R000055687 |
| Scientific Title | Development of a predictive model for patients with stroke |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2022/09/10 13:07:01 |
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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
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
ptnaka@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055687
