UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the influence of reproducibility gripping action and appearance of the electric prosthetic hand upon sense of agency
Title of the study (Brief title)	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	Akio Gofuku
Organization	Okayama University
Division name	Graduate School of Interdisciplinary Science and Engineering in Health Systems
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	Kenji Sato
Organization	Kawasaki Medical School
Division name	Department of Anesthesiology and Intensive Care Medicine 1
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028693