UMIN-CTR Clinical Trial

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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