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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040568
Receipt No. R000046304
Scientific Title The relationships between sleep and the mental and physical conditions of senior patients treated in rehabilitation wards following stroke
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/28

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Basic information
Public title The relationships between sleep and the mental and physical conditions of senior patients treated in rehabilitation wards following stroke
Acronym The relationships between sleep and ward life for patients with stroke
Scientific Title The relationships between sleep and the mental and physical conditions of senior patients treated in rehabilitation wards following stroke
Scientific Title:Acronym The relationships between sleep and ward life for patients with stroke
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 was to find a solution to reduce patients' EDS.
Basic objectives2 Others
Basic objectives -Others prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patients were evaluated one week after admission.
Primary outcomes are sleep conditions.
Key secondary outcomes

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients were treated at the rehabilitation facility in Japan
2. Sixty-five years of age or more
3. Diagnosed to have stroke
4.No signs of cognitive decline, as determined by the Mini-Mental State Examination, which had a cut-off value of >23
Key exclusion criteria 1.Patients not permitted to participate in the study by their doctors due to risks associated with assessing mental and physical function
2.With severe memory impairment or aphasia.
Target sample size 17

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Nakagawa
Organization (1)Graduate School of Health Sciences, Kobe University, Kobe, Japan
(2)Senri-chuo Hospital, Japan
Division name (1)Department of Rehabilitation Science (2)Department of Rehabilitation
Zip code (1)654-0142 (2)560-0082
Address (1)7-10-2 Tomogaoka Suma-ku, Kobe-shi, Hyogo-ken, Japan (2)1-4-3 Sinsenrihigashi-machi, Toyonaka-shi, Osakahu, Japan
TEL (1)078-792-2555(2)06-6834-1100
Email 172k206k@stu.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Nakagawa
Organization Graduate School of Health Sciences, Kobe University, Kobe, Japan
Division name Department of Rehabilitation Science
Zip code 654-0142
Address 7-10-2 Tomogaoka Suma-ku, Kobe-shi, Hyogo-ken 654-0142, Japan
TEL 078-792-2555
Homepage URL
Email 172k206k@stu.kobe-u.ac.jp

Sponsor
Institute Graduate School of Health Sciences, Kobe University, Kobe, Japan
Institute
Department

Funding Source
Organization Graduate School of Health Sciences, Kobe University, Kobe, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Senri-chuo Hospital, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethics committee of Senri-chuo Hospital
Address 1-4-3 Sinsenrihigashi-machi, Toyonaka-shi, Osakahu 560-0082, Japan
Tel 06-6834-1100
Email naritomi@kyowakai.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 千里中央病院(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 17
Results Congress: The 53th Japanese Occupational Therapy Congress (September 6-8, 2019, in Fukuoka).
Results date posted
2020 Year 05 Month 28 Day
Results Delayed
Delay expected
Results Delay Reason I will submit the results to a paper.
Therefore, I cannot publish the results.
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 Completed
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 08 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigated the relationship between sleep status (sleep-hours, number of sleep, sleep efficiency) and mental function, physical function, ward activity, and, measures of Movement and Activities of Daily Living.

Management information
Registered date
2020 Year 05 Month 28 Day
Last modified on
2020 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046304

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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