UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024967 |
|---|---|
| Receipt number | 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 22:00:33 |
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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
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
k.sato@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028693
