UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050026 |
|---|---|
| Receipt number | R000056990 |
| Scientific Title | A crossover trial on the effect of the wearable assistive suit on reducing the burden of caregivers |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2023/01/18 18:23:39 |
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Basic information
Public title
A crossover trial on the effect of the wearable assistive suit on reducing the burden of caregivers
Acronym
Wearable assistive suit (Muscle Suit) study
Scientific Title
A crossover trial on the effect of the wearable assistive suit on reducing the burden of caregivers
Scientific Title:Acronym
Wearable assistive suit (Muscle Suit) study
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the reduction of the burden of transfer assistance movements of medical care workers using wearable assistive suit, Muscle Suit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Baseline: Demographics, years of caregiving experience, physical fitness (grip strength), etc.
Objective measures: pulse rate, blood pressure, caregiving time, FIM, etc.
Subjective indicators:
Impression of caregiving burden (NRS; Numerical Rating Scale), etc.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Medical care staff, the study subjects, wear the Muscle Suit, one of the wearable assistive suits, to perform their usual transfer assistance, and compare the impression of care burden, assistance time, etc. with or without the Muscle Suit.
Crossover trial; ABA method
A. Transfers without the Muscle Suit, as usual
Interventions/Control_2
Medical care staff, the study subjects, wear the Muscle Suit, one of the wearable assistive suits, to perform their usual transfer assistance, and compare the impression of care burden, assistance time, etc. with or without the Muscle Suit.
Crossover trial; ABA method
B. Transfers with the Muscle Suit, intervention
Interventions/Control_3
Medical care staff, the study subjects, wear the Muscle Suit, one of the wearable assistive suits, to perform their usual transfer assistance, and compare the impression of care burden, assistance time, etc. with or without the Muscle Suit.
Crossover trial; ABA method
A. Transfers without the Muscle Suit, as usual
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults between the age of 20 and 70.
Medical care workers working un facilities and hospitals.
Those currently performing transfer assistance duties.
Those who have agreed to participate in this study.
Key exclusion criteria
Those currently undergoing treatment for orthopedic conditions are not eligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Meguro |
Organization
Tohoku University
Division name
New Industry Creation Hatchery Center, Geriatric Behavioral Neurology Project
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7359
kenichi.meguro.e6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Kasai |
Organization
Tohoku University
Division name
New Industry Creation Hatchery Center, Geriatric Behavioral Neurology Project
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7359
Homepage URL
mari.kasai.6c@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Kenichi Meguro
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo University of Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
西仙台病院（宮城県）、三友堂病院（山形県）、一心病院（東京都）、SGグループ関連病院（宮城県ほか）、PFC HOSPITAL（宮城県）、栗原医院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056990
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
