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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042390
Receipt No. R000048391
Scientific Title Identification of effects related to reducing the physical burden associated with bathing care assistance using bathing support equipment
Date of disclosure of the study information 2020/11/12
Last modified on 2020/11/09

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Basic information
Public title Identification of effects related to reducing the physical burden associated with bathing care assistance using bathing support equipment
Acronym Identification of physical burden reduction effect by bathing care support robot
Scientific Title Identification of effects related to reducing the physical burden associated with bathing care assistance using bathing support equipment
Scientific Title:Acronym Identification of physical burden reduction effect by bathing care support robot
Region
Japan

Condition
Condition Healthy persons
Classification by specialty
Rehabilitation medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identification of physical burden reduction effect by bathing support robot
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes EMG of bilateral gluteus maximus, biceps brachii, quadratus lumborum, and erector spinae muscles in the caregiver
Key secondary outcomes Physical and psychological burden (VAS) and questionnaire survey of care recipients

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Muscle activity in normal bathing assistance
Interventions/Control_2 Muscle activity when using a bathing support robot in bathing assistance
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Up to 30 staff members belonging to Convalescent and Community Comprehensive Care Wards of National Center of Geriatrics and Gerontology and the care recipients (Maximum 15 people), who uses the bathing assist robot
2. Among them, the consent of the document was obtained with the free will of the person who participated in this study.
3. Staff members who have low back pain on a daily basis are excluded.
Key exclusion criteria 1. Patients with a history of brain disease, neurological/muscular disease, heart disease, epilepsy
2. Having a pacemaker
3. Pregnant women
4. Other persons who are deemed inappropriate by the Research Director or Research Divider
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Center of Assistive Robotics and Rehabilitation for Longevity and Good Health
Zip code 4748511
Address 7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL 0562462311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Kato
Organization National Center for Geriatrics and Gerontology
Division name Lab Clinical Evaluation with Robotics, Center of Assistive Robotics and Rehabilitation for Longevity
Zip code 474-8511
Address 7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL 0562462311
Homepage URL
Email kk0724@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 National Center for Geriatrics and Gerontology, Ethics and Conflicts of Interest Committee
Address 7-430, Morioka, Obu, Aichi 474-8511, JAPAN
Tel +81-562-462311
Email ik7710@ncgg.go.jp

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 国立研究開発法人 国立長寿医療研究センター リハビリテーション科部・回復期リハビリテーション病棟・地域包括ケア病棟(愛知県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 12 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 Open public recruiting
Date of protocol fixation
2020 Year 07 Month 26 Day
Date of IRB
2020 Year 09 Month 11 Day
Anticipated trial start date
2020 Year 09 Month 29 Day
Last follow-up date
2022 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
2020 Year 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048391

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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