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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035327
Receipt No. R000040051
Scientific Title Relationship between post-stroke fatigue and autonomic nerve function: a fundamental research to develop an effective treatment for post-stroke fatigue
Date of disclosure of the study information 2018/12/21
Last modified on 2019/06/24

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Basic information
Public title Relationship between post-stroke fatigue and autonomic nerve function: a fundamental research to develop an effective treatment for post-stroke fatigue
Acronym Autonomic nerve function in individuals with post-stroke fatigue
Scientific Title Relationship between post-stroke fatigue and autonomic nerve function: a fundamental research to develop an effective treatment for post-stroke fatigue
Scientific Title:Acronym Autonomic nerve function in individuals with post-stroke fatigue
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 relationship between post-stroke fatigue and autonomic nerve function in individuals with subacute stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variability
Key secondary outcomes The number of postural orthostatic tachycardia syndrome
The number of orthostatic hypotension
The number of neurally mediated hypotension
Changes in heart rate during a conventional active standing test
Changes in blood pressure during a conventional active standing test

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. First-ever stroke
2. Stroke within 1 to 6 months
3. Unilateral hemiparetic stroke
4. No severe cognitive impairment (a Mini-mental State Examination score of 24 or more)
5. Age between 40 and 80 years
6. Able to stand up without manual assistance
7. Consent to participate in this study
Key exclusion criteria 1. Arrhythmia such as atrial fibrillation
2. Cognitive impairment leading to inability to cooperate
3. Using a cardiac pacemaker
4. A heart rate of more than 120 bpm or a systolic blood pressure of less than 90 mmHg during supine at rest
5. Other neurologic conditions in addition to stroke
Target sample size 100

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
TEL 0263-37-2413
Email oyake.kazuaki@hotmail.co.jp

Public contact
Name of contact person
1st name Keita
Middle name
Last name Sue
Organization Kakeyu-Misayama rehabilitation center
Division name Department of Physical Therapy
Zip code 386-0396
Address 1308 Kakeyuonsen, Ueda-city, Nagano
TEL 0268-44-2111
Homepage URL
Email keitasue@live.jp

Sponsor
Institute Kakeyu-Misayama rehabilitation center
Institute
Department

Funding Source
Organization Grant-in Aid for Young Scientists
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Shinshu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kakeyu-Misayama rehabilitation center
Address 1308 Kakeyuonsen, Ueda-city, Nagano
Tel 0268-44-2111
Email pt-b@kakeyu-hp.com

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 鹿教湯三才山リハビリテーションセンター

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 21 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
2018 Year 12 Month 20 Day
Date of IRB
2018 Year 12 Month 08 Day
Anticipated trial start date
2019 Year 01 Month 01 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

Other
Other related information To investigate the relationship between post-stroke fatigue and autonomic nerve function in a cross-sectional design.
To examine whether reducing post-stroke fatigue is related to improving autonomic nerve function.

Management information
Registered date
2018 Year 12 Month 20 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040051

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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