UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of the influence of the appearance factor of the elecrtic prosthetic hand on Sense of Agency
Title of the study (Brief title)	A Study of the influence of the appearance factor of the elecrtic prosthetic hand on 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 (PLP), which are likely resistant to drug therapy and considered there are no effective treatments, are named intractable pain. Mirror visual feedback therapy has been done as the one of the treatments. In this therapy, it is reported that the pain levels of the patients with CRPS and PLP are alleviated due to observe the movement that reflected their own normal limbs on the mirror. The pain alleviation, when using prosthetic hand called Sauerbruch prosthesis that can be moved by user's intended, is also reported. Based on these case, we consider that Sense of Agency (SA) is important to reduce the pain. SA is a feeling that motion in accordance with a certain purpose is occured on its own intention. It is founded SA could be ambiguous when there is a delay in input and actual operation. In present study, we aim to clealify the occurence defference of SA by changing the appearances of the electric prosthetic hand and the delay time that is from input to acual motion of the one.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We collect SA and appearance reproducibility by questionnaire when the participants manipulate the electric prosthetic hand.
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	Intervention toward healthy people is made for up to two hours. In this group, the participants manipulate the electric prosthetic hand of which all fingers are properly designed. The input-action time of the electric prosthetic hand is set to delay randomly, and the questionnaire is used to evaluate SA difference in delay time.
Interventions/Control_2	Intervention toward healthy people is made for up to two hours. In this group, the participants manipulate the electric prosthetic hand of which only index finger is properly designed. The input-action time of the electric prosthetic hand is set to delay randomly, and the questionnaire is used to evaluate SA difference in delay time.
Interventions/Control_3	Intervention toward healthy people is made for up to two hours. In this group, the participants manipulate the electric prosthetic hand of which only index finger is inadequately designed. The input-action time of the electric prosthetic hand is set to delay randomly, and the questionnaire is used to evaluate SA difference in delay time.
Interventions/Control_4	Intervention toward healthy people is made for up to two hours. In this group, the participants manipulate the electric prosthetic hand of which all fingers are inadequately designed. The input-action time of the electric prosthetic hand is set to delay randomly, and the questionnaire is used to evaluate SA 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	18 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 18 years old.
Key exclusion criteria	It is difficult to visually recognize the motion of the electric prosthetic hand.
Target sample size	40

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-shi,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	Self funding
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	2019 Year 01 Month 29 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 26 Day
Anticipated trial start date	2018 Year 12 Month 26 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	2018 Year 10 Month 29 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039542