UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the joint excursion training by the nurse of the cerebrovascular disorder patient in our ward
Title of the study (Brief title)	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	kumakura michiko
Organization	Saitama Medical Center
Division name	Nursing department
Address	Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL	0492283659
Email	kuma12150323@yahoo.co.jp

Public contact
Name of contact person	kumakura michiko
Organization	Nursing department
Division name	Nursing department
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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