UMIN-CTR Clinical Trial

Public title

Relationship between vestibular function and balance function in patients with stroke

Acronym

Relationship between vestibular function and balance function in patients with stroke

Scientific Title

Relationship between static and dynamic subjective visual vertical and balance function in patients with subacute stroke

Scientific Title:Acronym

Relationship between subjective visual vertical and balance function in patients with subacute stroke

Region

Japan

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the relationship between vestibular function (e.g. SVV) and balance function in patients with subacute stroke.

Basic objectives2

Others

Basic objectives -Others

Relationship between SVV and balance function

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Static and dynamic subjective visual vertical

Key secondary outcomes

Mini-BESTest
Upright balance assessment based on the force plate (total path length, amplitude, etc.)
MMSE (Mini Mental State Examination)
Age
NIHSS ((National Institutes of Health Stroke Scale)
FMA (Fugl Meyer Assessment)
FIM (Functional Independence Measure)
TIS (Trunk Impairment Scale)
Line bisection test
SRRST (Subjective Risk Rating of Specific Tasks)
Whether or not a fall has occurred

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with first stroke.
Able to hold a standing position on their own or with assistance.
Those with no vision or visual field problems.

Key exclusion criteria

Individuals with orthopedic conditions that may affect balance measurements.
Those with dementia.
Those with aphasia.
Those with communication disorders.

Target sample size

90

Name of lead principal investigator

1st name	Shota
Middle name
Last name	Hayashi

Organization

Gunma Paz University

Division name

Department of Physical Therapy

Zip code

370-0006

Address

1-7-1 Tonyamachi, Takasaki, Gunma

TEL

027-365-3366

Email

mane.shota@gmail.com

Name of contact person

1st name	Shota
Middle name
Last name	Hayashi

Organization

Gunma Paz University

Division name

Department of Physical Therapy

Zip code

370-0045

Address

1-7-1 Tonyamachi, Takasaki, Gunma

TEL

08012117055

Homepage URL

Email

mane.shota@gmail.com

Institute

Gunma Paz University

Institute

Department

Personal name

Organization

Gunma Paz University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Gunma Paz University

Address

1-7-1 Tonyamachi, Takasaki, Gunma

Tel

027-365-3366

Email

s-hayashi@paz.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

沼田脳神経外科循環器科病院（群馬県）
埼玉よりい病院（埼玉県）

Date of disclosure of the study information

2023

Year

10

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

09

Month

13

Day

Date of IRB

2023

Year

07

Month

26

Day

Anticipated trial start date

2023

Year

10

Month

15

Day

Last follow-up date

2025

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In this study, we will investigate the relationship between vestibular and balance function in patients with subacute stroke.

Basic information andinitial assessment will be performed during the period of stable condition after admission (1-2 weeks after admission).Basic Information
Age, sex, height, weight, name of disease, site of disability, side of paralysis, presence of dizziness, cognitive function(MMSE)Vestibular Function Tests
Static and dynamic subjective visual vertical(SVV)

Balance function
Mini-BESTest, Total path length, amplitude, etc.according to 6 conditions(eye opening/hard surface, eye closing/hard surface, eye opening/soft surface, eye closing/soft surface, optokineticstimulation (left/right torsional stimulation)/hard surface).Physical function
NIHSS, FMA, FIM, TIS, Line bisection test

Fall risk
SRRST

Subsequently, 3 months and 6 months after discharge, the patient or familymember will be asked by telephone interview whether or not they have had a fall.

Registered date

2023

Year

10

Month

04

Day

Last modified on

2024

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059495