UMIN-CTR Clinical Trial

Basic information
Public title	The development of the positioning care practice model to prevent the joint contracture of long-term bedridden elderly people due to muscle tonus.
Acronym	The development of the positioning care to prevent the joint contracture of long-term bedridden elderly people
Scientific Title	The development of the positioning care practice model to prevent the joint contracture of long-term bedridden elderly people due to muscle tonus.
Scientific Title:Acronym	The development of the positioning care to prevent the joint contracture of long-term bedridden elderly people
Region	Japan

Condition
Condition	Joint contracture
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop the practical positioning care practice model to alleviate and prevent the joint contracture of long-term bedridden elderly people in the muscle tonus , and examine the effectiveness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The range of joint motion, MAS muscle tonus , myosclerosis degree, autonomic function, vital signs, images by digital cameras, QOL assessment, and VAS subjective evaluation before and after (first day, 30 days, 60 days, or 90 days after) the intervention.
Key secondary outcomes	A questionnaire survey on the effectiveness of the new positioning care intervention model.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	For the elderly people surveyed, replace the position change performed in every 2 to 3 hours every day with the positioning care practice model for 3 months. On completion of the intervention 1 for the elderly people surveyed, after 3-month implementation of the new positioning care practical model by the nurses and caretakers surveyed, conduct a questionnaire survey.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The elderly people who have been hospitalized for over 1 month and bedridden for over 1 month as well as have muscle tonus , and whose (the family) consent to the participation in this study can be obtained. Those who can provide an explanation on the new positioning practice model to the nurses and caretakers surveyed who work 3 or more days a week (100 people in total), and after 1-month training, conduct it for 3 months in each hospital ward.
Key exclusion criteria	patients whom their attending physician does not allow to participate in the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Miyo Kaneda
Organization	Aichi Kiwami College of Nursing
Division name	home care nursing
Zip code
Address	5-4-1Jyouganntoori,Itinomiya-si,Aiti
TEL	0586-28-8110
Email	m.kaneda.t@aichi-kiwami.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Miyo Kaneda
Organization	University of Human Environments
Division name	Department of Nursing,Graduate School of University of Human Environments
Zip code
Address	3-220Ebata-cho,Oobu-si,Aiti
TEL	0562-43-0701
Homepage URL
Email	m.kaneda.t@aichi-kiwami.ac.jp

Sponsor
Institute	University of Human Environments
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 02 Month 18 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	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 17 Day
Date of IRB	2016 Year 08 Month 18 Day
Anticipated trial start date	2016 Year 11 Month 08 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 11 Month 30 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2021 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030026