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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024967
Receipt No. R000028693
Scientific Title Study of the influence of reproducibility gripping action and appearance of the electric prosthetic hand upon sense of agency
Date of disclosure of the study information 2017/02/10
Last modified on 2018/05/30

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Basic information
Public title Study of the influence of reproducibility gripping action and
appearance of the electric prosthetic hand upon sense of agency
Acronym Study of the influence of reproducibility gripping action and
appearance of the electric prosthetic hand upon sense of agency
Scientific Title Study of the influence of reproducibility gripping action and
appearance of the electric prosthetic hand upon sense of agency
Scientific Title:Acronym Study of the influence of reproducibility gripping action and
appearance of the electric prosthetic hand upon sense of agency
Region
Japan

Condition
Condition Healthy People
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Complex regional pain syndrome (CRPS) and phantom limb pain are resistant to drug therapy and there is no effective treatment and it is called intractable pain.
It is reported that one of the treatments for these treatments is mirror therapy. In mirror therapy, the normal paw is reflected on the mirror, and the pain is alleviated by observing the movement. Pain relief by observing movement has also been reported in the operation of electric prosthetic hands.
We think that it is important to reduce the pain by observing the motion, it is important to generate sense of agency, which is a feeling that motion in accordance with a certain purpose is acted on its own initiative. Sense of agency is revealed to be ambiguous when there is a delay in input and actual operation.
In this study, we will clarify the difference in the occurrence of sense of agency by changing the appearance and motion of the electric prosthesis by causing delays in the input to the electric prosthetic hand and the actual movement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We collect changes sense of agency by using questionnaire when the electric prosthetic hands change the reproducibility gripping action and the appearance.
Changes sense of agency are collected by delaying input and actual motion, prepares plural delay times and presents them at random.
Participants answer at which delay time the feeling of using themselves has disappeared.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Healthy people handle electric prosthetic hands with high reproducibility gripping action and appearance. The delay time of the electric prosthetic hand is presented randomly, and a questionnaire is used to evaluate how much sense of movement is obtained by the difference in delay time.
Interventions/Control_2 Healthy people handle electric prosthetic hands with low reproducibility gripping action and high appearance. The delay time of the electric prosthetic hand is presented randomly, and a questionnaire is used to evaluate how much sense of movement is obtained by the difference in delay time.
Interventions/Control_3 Healthy people handle electric prosthetic hands with high reproducibility gripping action and low appearance. The delay time of the electric prosthetic hand is presented randomly, and a questionnaire is used to evaluate how much sense of movement is obtained by the difference in delay time.
Interventions/Control_4 Healthy people handle electric prosthetic hands with low reproducibility gripping action and appearance. The delay time of the electric prosthetic hand is presented randomly, and a questionnaire is used to evaluate how much sense of movement is obtained by the difference in delay time.
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. Consenting to voluntary participation of study with consent form.
2. Over 20 years old.
Key exclusion criteria It is difficult to visually recognize the motion of the electric prosthetic hand.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Gofuku
Organization Okayama University
Division name Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code
Address #408 Studies of Natural Science and Technology,3-1-1,Tsushimanaka,kita-ku,Okayama-City, Okayama Prefecture, 700-0082,Japan
TEL 086-251-8022
Email fukuchan@sys.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Sato
Organization Kawasaki Medical School
Division name Department of Anesthesiology and Intensive Care Medicine 1
Zip code
Address 577, Matsusima, Kurashiki-City, Okayama Prefecture, 701-0192,Japan
TEL 086-462-1111
Homepage URL
Email k.sato@med.kawasaki-m.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 10 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 23 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028693

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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