UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049620 |
|---|---|
| Receipt number | R000056507 |
| Scientific Title | Explore of Minimal clinically important differences (MCID) of the Scale for the Assessment and Rating of Ataxia (SARA) and the Vertigo Symptom Scale- short form (VSS-sf) in stroke. A multicenter prospective observational study. |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/26 11:25:49 |
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Basic information
Public title
Explore of Minimal clinically important differences (MCID) of the Scale for the Assessment and Rating of Ataxia (SARA) and the Vertigo Symptom Scale- short form (VSS-sf) in stroke. A multicenter prospective observational study.
Acronym
Explore of Minimal clinically important differences (MCID) of the Scale for the Assessment and Rating of Ataxia (SARA) and the Vertigo Symptom Scale- short form (VSS-sf) in stroke. A multicenter prospective observational study.
Scientific Title
Explore of Minimal clinically important differences (MCID) of the Scale for the Assessment and Rating of Ataxia (SARA) and the Vertigo Symptom Scale- short form (VSS-sf) in stroke. A multicenter prospective observational study.
Scientific Title:Acronym
Explore of Minimal clinically important differences (MCID) of the Scale for the Assessment and Rating of Ataxia (SARA) and the Vertigo Symptom Scale- short form (VSS-sf) in stroke. A multicenter prospective observational study.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore minimal clinically important differences (MCID) of SARA (Scale for the Assessment) and VSS-sf (Vertigo Symptom Scale - short form).
Basic objectives2
Others
Basic objectives -Others
To explore minimal clinically important differences (MCID) of outcome about ataxia and vertigo/dizziness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scale for the Assessment and Rating of Ataxia
Key secondary outcomes
Vertigo Symptom Scale- short form
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)Stroke, Infratentorial CI or ICH
(2)ataxia (SARA>0)
(3)no/some palsy and sensory disturbance"
Key exclusion criteria
(1) before this stroke, modified Rankin Scale : mRS=>2
(2) Mini Mental State Examination-J (MMSE-J) <= 23
(3) dropout from rehabilitation program
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Yoshikawa |
Organization
Sakurakai Hospital
Division name
Department of Rehabilitation
Zip code
589-0011
Address
5-2610-1 Handa, Sayama, Osaka
TEL
072-366-5757
s8t4y6k3@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Yoshikawa |
Organization
Sakurakai Hospital
Division name
Department of Rehabilitation
Zip code
589-0011
Address
5-2610-1 Handa, Sayama, Osaka
TEL
072-366-5757
Homepage URL
s8t4y6k3@gmail.com
Sponsor or person
Institute
Sakurakai Hospital
Institute
Department
Personal name
Funding Source
Organization
Shijonawate Gakuen University
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
Shijonawate Gakuen University
Address
Hojo 5-11-10, Daito, Osaka
Tel
072-863-5043
h-motoyama@un.shijonawate-gakuen.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 01 | 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
Study design: Cross-sectional study
Recruitment methods: Patients admitted to our hospital ward on or after January 10, 2023 who meet the selection and exclusion criteria are included.
Outcomes: Scale for assessment and rating of ataxia (SARA), Vertigo Symptom Scale- short form (VSS-sf)
Management information
Registered date
| 2022 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056507
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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