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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042152
Receipt No. R000048114
Scientific Title Development of a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table
Date of disclosure of the study information 2020/11/01
Last modified on 2021/05/17

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Basic information
Public title Development of a method for assessing orthostatic hypotension in individuals with stroke
Acronym Development of a method for assessing orthostatic hypotension in individuals with stroke
Scientific Title Development of a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table
Scientific Title:Acronym Development of a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table
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 develop a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table by applying the sit-up test.
Basic objectives2 Others
Basic objectives -Others 1. To examine the relationship and difference of orthostatic changes in blood pressure and hemodynamics between the head up tilt test and the sit-up test.
2. To identify blood pressure cut-offs to diagnose orthostatic hypotension during the sit-up test.
3. To investigate the influence of difference in supine time before sitting up on the change in blood pressure during the sit-up test.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic blood pressure
Key secondary outcomes Diastolic blood pressure
Cardiac output
Heart rate
Stroke volume
Total peripheral resistance
Subjective symptoms

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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. First-ever stroke
2. Stroke within 1 to 6 months
3. No severe cognitive impairment (a Mini-Mental State Examination score of 24 or more)
4. Consent to participate in this study
Key exclusion criteria 1. Limited range of motion and/or pain that affect the head-up tilt test and the sit-up test
2. Bilateral hemiparetic stroke
3. Mental impairment leading to inability to corporate
4. Unstable medical conditions
5. Other neurologic conditions in addition to stroke
6. Unable to measure blood pressure from the nonparetic arm due to a fracture of the humerus and/or after surgery for breast cancer
7. Inappropriate patients due to other reasons
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuaki
Middle name
Last name Oyake
Organization Shinshu University
Division name Department of Physical Therapy
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL +81-263-37-2413
Email k_oyake@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Kazuaki
Middle name
Last name Oyake
Organization Shinshu University
Division name Department of Physical Therapy
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL +81-263-37-2413
Homepage URL
Email k_oyake@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Bay Rehabilitation Hospital
Saku Central Hospital
Kakeyu Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Shinshu University
Address Ethics committee of Shinshu University
Tel 0263-37-2572
Email mdrinri@shinshu-u.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 東京湾岸リハビリテーション病院(千葉県)
佐久総合病院(長野県)
鹿教湯病院(長野県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 10 Day
Date of IRB
2020 Year 09 Month 10 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. To examine the relationship and difference of orthostatic changes in blood pressure and hemodynamics between the head up tilt test and the sit-up test.
2. To identify blood pressure cut-offs to diagnose orthostatic hypotension during the sit-up test.

Management information
Registered date
2020 Year 10 Month 18 Day
Last modified on
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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