UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034685 |
|---|---|
| Receipt number | R000039542 |
| Scientific Title | A Study of the influence of the appearance factor of the elecrtic prosthetic hand on Sense of Agency |
| Date of disclosure of the study information | 2019/01/29 |
| Last modified on | 2018/11/14 18:47:36 |
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Basic information
Public title
A Study of the influence of the appearance factor of the elecrtic prosthetic hand on Sense of Agency
Acronym
A Study of the influence of the appearance factor of the elecrtic prosthetic hand on Sense of Agency
Scientific Title
A Study of the influence of the appearance factor of the elecrtic prosthetic hand on Sense of Agency
Scientific Title:Acronym
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
| 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-shi,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
Self funding
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
| 2019 | Year | 01 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 12 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039542
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