UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026136 |
|---|---|
| Receipt number | R000030026 |
| 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. |
| Date of disclosure of the study information | 2017/02/18 |
| Last modified on | 2021/03/09 17:38:55 |
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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
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
m.kaneda.t@aichi-kiwami.ac.jp
Sponsor or person
Institute
University of Human Environments
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030026
| 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 |
