UMIN-CTR Clinical Trial

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
Email	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
Email	s8t4y6k3@gmail.com

Sponsor
Institute	Sakurakai Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056507