UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046348 |
|---|---|
| Receipt number | R000052878 |
| Scientific Title | Inter- and intra-rater reliability of the subjective postural vertical in stroke patients |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2023/12/23 09:55:21 |
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Basic information
Public title
Investigation of the reliability of subjective postural vertical in stroke patients
Acronym
Investigation of the reliability of subjective postural vertical in stroke patients
Scientific Title
Inter- and intra-rater reliability of the subjective postural vertical in stroke patients
Scientific Title:Acronym
Inter- and intra-rater reliability of the subjective postural vertical in stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the inter- and intra-rater reliability of subjective postural vertical in stroke patients.
Basic objectives2
Others
Basic objectives -Others
Reliability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inter- and intra rater reliability
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients after single hemorrhagic or ischemic hemispheric stroke who can practice for more than 40 minutes including wheelchair riding, sitting and standing practice during physical therapy and occupational therapy
Key exclusion criteria
Patients with a history of neurological diseases such as stroke, diseases related to vestibular function, orthopedic surgeries in areas other than the forearm, or psychiatric diseases.
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
30
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Ueta |
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
k_ueta_0511105@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Ueta |
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
k_ueta_0511105@yahoo.co.jp
Sponsor or person
Institute
JCHO Hoshigaoka Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
nakano-megumi@hoshigaoka.jcho.go.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
| 2021 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study design: Cross-sectional study
Recruitment methods: Patients admitted to our hospital's convalescence rehabilitation ward on or after December 10, 2021 who meet the selection and exclusion criteria are included.
Outcomes: Subjective postural vertical
Management information
Registered date
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
