UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042390
Receipt number 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 2023/05/15 15:22:47

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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 or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



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

https://www.mdpi.com/2076-3417/12/19/10131

Publication of results

Published


Result

URL related to results and publications

https://www.mdpi.com/2076-3417/12/19/10131

Number of participants that the trial has enrolled

8

Results

Four caregivers performed simulated assisting movements for four patients (subjects) with hemiplegia and other conditions, and the degree of psychological and physical burden was investigated by electromyographic measurement and questionnaire with and without a robotic care device (bathing assistance robot). When the bathing assistance device was used, the assisting action was changed from direct assistance to watchful waiting, and muscle activity decreased significantly accordingly.

Results date posted

2023 Year 05 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 10 Month 09 Day

Baseline Characteristics

Patients (subjects) who need assistance with bathing due to hemiplegia, etc.

Participant flow

Patients admitted to the hospital in the National Center for Geriatrics and Gerontology and their rehabilitation personnel were recruited.

Adverse events

Non

Outcome measures

Extracted the amount of muscle activity of caregivers by electromyography in use and non-use of the robot to quantitatively evaluate the physical burden.

Plan to share IPD

Individual case data will not be shared in this study.

IPD sharing Plan description

Individual case data will not be shared in this study.


Progress

Recruitment status

Completed

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

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 11 Month 09 Day

Last modified on

2023 Year 05 Month 15 Day



Link to view the page

Value
https://center6.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