UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032876 |
|---|---|
| Receipt number | R000037485 |
| Scientific Title | Effect of the joint excursion training by the nurse of the cerebrovascular disorder patient in our ward |
| Date of disclosure of the study information | 2019/03/17 |
| Last modified on | 2018/06/05 16:31:20 |
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Basic information
Public title
Effect of the joint excursion training by the nurse of the cerebrovascular disorder patient in our ward
Acronym
Effect of the joint excursion training by the nurse of the cerebrovascular disorder patient in our ward
Scientific Title
Effect of the joint excursion training by the nurse of the cerebrovascular disorder patient in our ward
Scientific Title:Acronym
Effect of the joint excursion training by the nurse of the cerebrovascular disorder patient in our ward
Region
| Japan |
Condition
Condition
cerebrovascular disordrer
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The hospital plays the role of an acute hospital, and not only science and occupational therapists but also nurses need to actively rehabilitate. In addition, in the acute phase, as part of the treatment, the body is often restrained while performing whole body management and drain / respiratory management. By carrying out body restraint, it is likely to be linked to factors such as joint contracture of upper limbs and fingers, and we think that it is necessary to conduct rehabilitation by nurses other than rehabilitation. However, in reality, nursing for avoidance of severity is given priority, and prevention of complications and prevention of waste syndrome are left to the science and occupational therapist in the present situation. Therefore, in addition to the rehabilitation by the science and occupational therapist, this time, in January 2018 the nurse wanted to compare the effect of joint exercise training by aggressively performing training of joint range (hereinafter referred to as ROM training) Think.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient characteristics, awareness level, age, sex, disease, joint motion range angle measurement (wrist joint, elbow joint, shoulder joint, hip joint, knee joint, ankle joint), Brundstrom stage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
From the training start date of science and occupational therapist, ROM training of hand, elbow joint, shoulder joint, hip joint, knee joint, ankle joint by nurses was carried out at the time of posture change at 10:00 and 17:00 every day. 10 seconds 10 sets each for each joint.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clear awareness level admitted to our ward ~ Cerebrovascular disorder patients up to JCS III - 300 Cleared consciousness level transferred from GICU ~ Patients with cerebrovascular disorder up to JCS III - 300 (within 1 week of onset) and manual muscle strength test (MMT Patients 0 to 4
Key exclusion criteria
Patients with cerebrovascular disorder who are admitted to the East ward at the 5 th floor, those who exceed 1 week since onset, patients with manual muscle strength test (MMT) 5, patients and families can not obtain consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kumakura michiko |
Organization
Saitama Medical Center
Division name
Nursing department
Zip code
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL
0492283659
kuma12150323@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kumakura michiko |
Organization
Nursing department
Division name
Nursing department
Zip code
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL
0492283659
Homepage URL
kuma12150323@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 03 | Month | 17 | 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
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037485
| Research Plan | |
|---|---|
| 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 |
