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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032718
Receipt No. R000037309
Scientific Title Comparison of the burden on nurses and wheelchair-enabled patients due to different methods of toileting assistance with and without sit-to-stand lifts
Date of disclosure of the study information 2018/05/26
Last modified on 2019/06/12

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Basic information
Public title Comparison of the burden on nurses and wheelchair-enabled patients due to different methods of toileting assistance with and without sit-to-stand lifts
Acronym Burden on nurses and wheelchair-enabled patients from different toileting assistance methods
Scientific Title Comparison of the burden on nurses and wheelchair-enabled patients due to different methods of toileting assistance with and without sit-to-stand lifts
Scientific Title:Acronym Burden on nurses and wheelchair-enabled patients from different toileting assistance methods
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Electromyography (EMG) and goniometry will be used to evaluate the physical effects on nurses and compare the burden from conventional human-powered toileting assistance and newer assistance with sit-to-stand lifts. Also, a questionnaire survey on physical burden will be conducted with nurses and wheelchair-enabled patients to verify whether sit-to-stand lifts reduce physical burden associated with toileting assistance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle activity of surface EMG
Key secondary outcomes Goniometry
Questionnaires

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 toileting assistance method with sit-to-stand lift
Interventions/Control_2 toileting assistance method without sit-to-stand lift
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
24 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Nurses: Inpatient care experience of 3 years or more, and expertise in toileting assistance
Simulated patients: Healthy individuals 65 years of age or older
Key exclusion criteria Nurses: Acute low back pain
Simulated patient: individuals with motor disorder
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimi Kobayashi
Organization Kanagawa University of Human Services
Division name School of Nursing, Faculty of Health & Social Services
Zip code
Address 1-10-1 Heiseicho, Yokosuka,Kanagawa
TEL 048-828-2796
Email kobayashi-ktr@kuhs.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimi Kobayashi
Organization Kanagawa University of Human Services
Division name School of Nursing, Faculty of Health & Social Services
Zip code
Address 1-10-1 Heiseicho, Yokosuka, Kanagawa
TEL 048-828-2796
Homepage URL
Email kobayashi-ktr@kuhs.ac.jp

Sponsor
Institute Kanagawa University of Human Services
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 神奈川県立保健福祉大学

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 26 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 Completed
Date of protocol fixation
2018 Year 03 Month 29 Day
Date of IRB
2018 Year 01 Month 17 Day
Anticipated trial start date
2018 Year 05 Month 26 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 25 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037309

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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