UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050588 |
|---|---|
| Receipt number | R000056953 |
| Scientific Title | External validation of the clinical prediction model for gait function after stroke |
| Date of disclosure of the study information | 2023/03/28 |
| Last modified on | 2023/03/15 11:27:15 |
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Basic information
Public title
External validation of the clinical prediction model for gait function after stroke
Acronym
External validation of the clinical prediction model for gait function after stroke
Scientific Title
External validation of the clinical prediction model for gait function after stroke
Scientific Title:Acronym
External validation of the clinical prediction model for gait function after stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To externally validate a prognostic model of gait function in individuals with stroke.
Basic objectives2
Others
Basic objectives -Others
Update model
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FAC (functional ambulation category)
4, 6, 9, 16, 21, 24 weeks after onset of stroke
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) first-onset cerebral infarction or cerebral hemorrhage
(2) supratentorial hemispheric lesion
(3) hemiplegias
(4) allowed to get out of bed within 8 days after stroke onset
(5) walking independently before the stroke onset
(6) able to understand the instructions of the test
Key exclusion criteria
(1) reduced walking function due to any neurological or musculoskeletal disorder
(2) TIA (transient ischemic attack)
(3) walking independently within 8 days after the stroke onset
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ren |
| Middle name | |
| Last name | Takeda |
Organization
Numata Neurosurgery & Heart Disease Hospital
Division name
Department of Rehabilitation
Zip code
378-0014
Address
8 Sakaemachi, Numata-shi, Gunma
TEL
0278-22-5052
m13204013@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Miyata |
Organization
Ibaraki Prefectural University of Health Science
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2, Ami-Machi, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
miyatak@ipu.ac.jp
Sponsor or person
Institute
Numata Neurosurgery & Heart Disease Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Science
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
Numata Neurosurgery & Heart Disease Hospital
Address
8 Sakaemachi, Numata-shi, Gunma
Tel
0278-22-5052
nn-reha@kijokai.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 28 | 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 | 29 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study
Recruitment methods: Patients admitted to our hospital ward on or after April 1, 2023, who meet the selection and exclusion criteria are included.
Predictive model to be validated: Update Australian model (predictors: age, National Institutes of Health Stroke Scale (NIHSS), Scandinavian Stroke Scale (SSS)), TWIST tool (predictors: age, Manual Muscle Test (MMT), Berg Balance Scale (BBS))
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056953
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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