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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042273
Receipt No. R000048254
Scientific Title Functional recovery in post-stroke patients on hemodialysis during the convalescent phase; a comparison with those not undergoing hemodialysis
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/28

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Basic information
Public title Study on the nutritional status of hemodialysis patients and the necessity of rehabilitation
Acronym Recovery in post-stroke patients on hemodialysis
Scientific Title Functional recovery in post-stroke patients on hemodialysis during the convalescent phase; a comparison with those not undergoing hemodialysis
Scientific Title:Acronym Recovery in post-stroke patients on hemodialysis
Region
Japan

Condition
Condition hemodialysis patient
Classification by specialty
Nephrology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the difference of functional recovery during the convalescent phase between post-stroke patients with and without hemodialysis
Basic objectives2 Others
Basic objectives -Others The secondary purpose of this study is to clarify the difference of nutrition status during the convalescent phase between post-stroke patients with and without hemodialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is walking ability and Ability of daily living at discharge
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Comprehensive rehabilitation in convalescent rehabilitation hospital
Interventions/Control_2 Comprehensive rehabilitation in convalescent rehabilitation hospital with maintenance hemodialysis
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with a diagnosis of stroke
2) Hemiparesis at the admission to convalescent rehabilitation hospital
3) Walking disturbance due to the hemiparesis
4) Age at the admission between 18-100 years
Key exclusion criteria 1) Time between the stroke onset and the admission to convalescent rehabilitation hospital of more than 90 days
2) History of multiple stroke at admission
3) Have active physical or mental illness requiring acute medical management
4) Have significant disturbance of consciousness at the admission
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Takeki
Middle name
Last name Ishida
Organization International University of Health and Welfare Ichikawa Hospital
Division name Department of Rehabilitation Medicine
Zip code 272-0827
Address 6-1-14 Kounodai, Ichikawa city, Chiba 272-0827 Japan
TEL 0473751111
Email 17s3008@g.iuhw.ac.jp

Public contact
Name of contact person
1st name Takeki
Middle name
Last name Ishida
Organization International University of Health and Welfare Ichikawa Hospital
Division name Department of Rehabilitation Medicine
Zip code 272-0827
Address 6-1-14 Kounodai, Ichikawa city, Chiba 272-0827 Japan
TEL 0473751111
Homepage URL
Email 17s3008@g.iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization International University of Health and Welfare Ichikawa Hospital
Address 6-1-14 Kounodai, Ichikawa city, Chiba 272-0827 Japan
Tel 0473751111
Email s-rinri@iuhw.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
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 82
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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 31 Day
Date of IRB
2017 Year 05 Month 15 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 28 Day
Last modified on
2020 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048254

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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