UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052959 |
|---|---|
| Receipt number | R000060357 |
| Scientific Title | Relationship between the Oxfordshire Community Stroke Project classification and upper and lower extremity motor function and recovery in patients with acute cerebral infarction. |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/11/30 17:46:16 |
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Basic information
Public title
Can the Oxfordshire Community Stroke Project classification explain upper and lower extremity motor function and recovery in patients with acute cerebral infarction?
Acronym
Can the OCSP classification explain motor function and recovery in patients with acute cerebral infarction?
Scientific Title
Relationship between the Oxfordshire Community Stroke Project classification and upper and lower extremity motor function and recovery in patients with acute cerebral infarction.
Scientific Title:Acronym
Relationship between the OCSP classification and motor function and recovery in patients with acute cerebral infarction.
Region
| Japan |
Condition
Condition
Patients with cerebral infarction
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the OCSP classification and the Fugl-Meyer Assessment (FMA) motor scales in patients with acute cerebral infarction.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between the OCSP classification and the Fugl-Meyer Assessment (FMA) motor scales recovery in patients with acute cerebral infarction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxfordshire Community Stroke Project classification, Fugl-Meyer Assessment Motor Scale
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients admitted to our Stroke Care Unit (SCU) from February 2021 to January 2023
- Diagnosed as cerebral infarcts
Key exclusion criteria
- Diagnosed as cerebral hemorrhage
- Missing upper extremity Fugl-Myer Assesment (FMA) data
- Upper limb FMA scores of 65 or 66
- Lower limb FMA scores of 33 or 34
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Syuhei |
| Middle name | |
| Last name | Chiba |
Organization
Kitasato University Hsopital
Division name
Rehabilitation Department
Zip code
Rehabilitation Department
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
1zerozero81008@gmail.com
Public contact
Name of contact person
| 1st name | Syuhei |
| Middle name | |
| Last name | Chiba |
Organization
Kitasato University Hospital
Division name
Rehabilitation Department
Zip code
252-0329
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
Homepage URL
1zerozero81008@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Syuhei Chiba
Funding Source
Organization
Kitasato University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kanagawa Occupational Therapists Association
IRB Contact (For public release)
Organization
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-8111
1zerozero81008@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
| 2023 | Year | 12 | Month | 25 | 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 | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Data on FMA upper and lower extremity items
173 patients met the selection criteria and excluded the exclusion criteria
Kruskal-Walis test for association between initial and final FMA upper extremity items and initial clinical diagnosis group classification (OCSP)
Steel-Dwass test to determine if there was a difference between the initial and final FMA upper extremity assessment and the OCSP subitems.
Pearson's chi-square test to determine if there is a difference between the initial and final change in FMA upper extremity items and OCSP sub-items.
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060357
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| Registered date | File name |
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| Registered date | File name |
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