UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028703 |
|---|---|
| Receipt number | R000032860 |
| Scientific Title | Effects of myoelectric prosthetics Training Program in non-handicapped person |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2020/08/19 09:45:34 |
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Basic information
Public title
Effects of myoelectric prosthetics Training Program in non-handicapped person
Acronym
Effects of myoelectric prosthetics Training Program
Scientific Title
Effects of myoelectric prosthetics Training Program in non-handicapped person
Scientific Title:Acronym
Effects of myoelectric prosthetics Training Program
Region
| Japan |
Condition
Condition
Adult(non-handicapped person)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this research, focusing on basic operation training and applied operation training of the EMG prosthesis training program, it is aimed to clarify whether the EMG artificial hand training program has the effect on myoelectric prosthetic handling ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of Capacity for Myoelectric Control
Key secondary outcomes
Southampton Hand Assessment Procedure
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Basic operation training group / Applied operation training group
Intervention period 5 days
Training time 20 minutes
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are healthy who are over 20 years old and who were able to obtain consent of cooperation for the purpose of the research
Key exclusion criteria
Person who has experience of simulated myoelectric prosthesis in the past. Those who have injuries or the like that may affect the operation of simulated artificial hands during the past or research period. Person who is under 20 years old. Those who can not obtain consent to research cooperation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | jumpei |
| Middle name | |
| Last name | oba |
Organization
Kobe Gakuin University
Division name
fuculty of Rehabilitation
Zip code
651-2180
Address
518 Arise Ikawadanicho nishiku Kobe city
TEL
0789741551
j-oba@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | jumpei |
| Middle name | |
| Last name | oba |
Organization
Kobe Gakuin University
Division name
fuculty of Rehabilitation
Zip code
651-2180
Address
518 Arise Ikawadanicho nishiku Kobe city
TEL
0789741551
Homepage URL
http://www.kobegakuin.ac.jp/
j-oba@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobe Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
KOBE Gakuin university
Name of secondary funder(s)
KOBE Gakuin university
IRB Contact (For public release)
Organization
kobe gakuin university
Address
518arse ikawadanicho nishiku kobe city
Tel
078-927-1551
j-oba@reha.kobegakuin.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
神戸学院大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://ci.nii.ac.jp/naid/130007784990/
Publication of results
Partially published
Result
URL related to results and publications
https://ci.nii.ac.jp/naid/130007784990/
Number of participants that the trial has enrolled
20
Results
One hand task was block wood disk movement,and both hands task executed activities of Macrame.It was examined with the Box and Block Test and The Southampton Hand Assessment Procedure for myoelectric hand ability assessment,As a result,the hand opening ability was not different between the one hand task and both hands task,and both hand task was the object operation ability improves compared with the one hand task.
Results date posted
| 2020 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subject was 20 healthy people.and,
not experiense electrical prosthesis
Participant flow
Those who have obtained consent to the research contents in the open call.
Adverse events
nothing
Outcome measures
Box and Block Test
The Southampton Hand Assessment Procedure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032860
