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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032876
Receipt No. 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

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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
Email 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
Email kuma12150323@yahoo.co.jp

Sponsor
Institute Saitama Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037485

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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