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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | stroke | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 17 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | (1)Graduate School of Health Sciences, Kobe University, Kobe, Japan
(2)Senri-chuo Hospital, Japan |
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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 |
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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 | |
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 |
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 |
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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 |
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Results Delayed |
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Results Delay Reason | I will submit the results to a paper.
Therefore, I cannot publish the results. |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |