UMIN-CTR Clinical Trial

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028703
Receipt No. 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 (Ver. 3)

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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
Email 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/
Email j-oba@reha.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032860