UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040568 |
|---|---|
| Receipt number | 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 | 2024/03/22 10:16:40 |
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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
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
172k206k@stu.kobe-u.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences, Kobe University, Kobe, Japan
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/asiajot/19/1/19_22/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/asiajot/19/1/19_22/_article/-char/ja/
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
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients in rehabilitation hospital in Japan
Participant flow
Patients matching the criteria were selected.
Adverse events
Nothing
Outcome measures
Basic information, sleep states
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
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046304
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
