UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054920 |
|---|---|
| Receipt number | R000062562 |
| Scientific Title | The effect that nursing intervention to reorganize movement gives for the living functional recovery of the patient just after the stroke onset |
| Date of disclosure of the study information | 2024/07/11 |
| Last modified on | 2024/07/09 23:37:55 |
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Basic information
Public title
The effect that nursing intervention for the living functional recovery of the patient just after the stroke onset
Acronym
The effect that nursing intervention for the living functional recovery of the patient just after the stroke onset
Scientific Title
The effect that nursing intervention to reorganize movement gives for the living functional recovery of the patient just after the stroke onset
Scientific Title:Acronym
The effect that nursing intervention to reorganize movement gives for the living functional recovery of the patient just after the stroke onset
Region
| Japan |
Condition
Condition
stroke excluding subarachnoid hemorrhage
Classification by specialty
| Neurology | Neurosurgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focusing on a recovery for 1 month of a patient just after the stroke onset, and verify whether the nursing intervention which reorganizes a movement can be promoted a living functional recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The score of Functional Independence Measure on 4day, 8day, 15day, 22day, 29day after onset.
Key secondary outcomes
The score of Trunt control test and Vitality index n 4day, 8day, 15day, 22day, 29day after onset.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will implement nursing interventions to reconstruct movement. The intervention period was from day 4 to day 15 of onset.
Interventions/Control_2
The control group will receive current nursing care based on the hospital's standard nursing care plan. The intervention period was from day 4 to day 15 of onset.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 60 to 85 who have been diagnosed with cerebral infarction or cerebral hemorrhage.
Patients admitted to the Stroke care unit on the day of onset within 3 days of onset.
Patients whose severity National Institutes of Health Stroke Scale is in the range of 4 to 40 as determined by the doctor at the time of admission.
Patients with family members and relatives acting as legal guardians.
Key exclusion criteria
Patients who are not independent in Activity day living before admission.
If you have undergone intracranial decompression or are on a ventilator 48 hours after onset.
If there are serious complications such as respiratory or kidney dysfunction or gastrointestinal bleeding on the 3rd day of onset.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuyo |
| Middle name | |
| Last name | Suzuki |
Organization
University of Hyogo
Division name
School of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kita Oji-cho, Akashi-shi, Hyogo, Japan
TEL
078-925-9404
xxasg305@guh.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyo |
| Middle name | |
| Last name | Suzuki |
Organization
University of Hyogo
Division name
School of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kita Oji-cho, Akashi-shi, Hyogo, Japan
TEL
078-925-9404
Homepage URL
xxasg305@guh.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESERCH FUND
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board College of Nursing Art and Science, University of Hyogo Research Institute of Nursing Care for People and Community
Address
13-71 Kita Oji-cho, Akashi-shi, Hyogo, Japan
Tel
078-925-9404
emi_mukai@ofc.u-hyogo.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
| 2024 | Year | 07 | Month | 11 | 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
40
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062562
