UMIN-CTR Clinical Trial

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

Healthy People

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Okayama University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

23

Day

Last modified on

2018

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028693