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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002464
Receipt No. R000003016
Scientific Title Effect of the interception of the skin somatic sensations on the sensation of movement which is produced by the mechanical vibration to tendons.
Date of disclosure of the study information 2009/10/01
Last modified on 2010/05/21

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Basic information
Public title Effect of the interception of the skin somatic sensations on the sensation of movement which is produced by the mechanical vibration to tendons.
Acronym Illusion of motion sensation under local anesthesia
Scientific Title Effect of the interception of the skin somatic sensations on the sensation of movement which is produced by the mechanical vibration to tendons.
Scientific Title:Acronym Illusion of motion sensation under local anesthesia
Region
Japan

Condition
Condition amputee of upper limb(s)
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An artificial limb system which patients (who equipped with the system) is able to move voluntarily exactly as the intend will significantly increase their "Quality of Life".
In order to develop such an artificial limb system, feedback of motion sensation from the artificial limb system to the patient is essential.
It has been reported that stimulation of muscle spindles by giving mechanical vibration to the tendon transcutaneously induces illusions of movement (Goodwin et al. 1972; Roll et al. 1982; Collins et al. 1996). We also succeeded in evoking illusory sensation of arm movements by stimulation to muscle spindles. However, evoked illusions are limited to slow ones, and moreover, sometimes failed to evoke such illusory sensation.
It is suspected that activities of cutaneous mechanoreceptors by the vibration have some relation with this phenomena, and therefore, in these experiments, we try to block the effect of cutaneous mechanoreceptors by local anesthesia so that the relationship between the activation of muscle spindles and movement sensation should be evaluated properly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Velocity of the illusory movement which is evoked by giving vibration to the concerned tendon is to be evaluated. (Changes in the mean value and the standard deviation with respect to condition of tendon vibration are investigated.)
Ratio of the number of cases in which illusion of arm movement is evoked by the tendon vibration to that of the total trials is also to be studied.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 First, tendons are vibrated mechanically by a vibrator under the conditions that cutaneous mechanoreceptors are not blocked.
Then local anesthetic agent (Carbocaine (1%):not more than 2ml) is injected subcutaneously so that cutaneous mechanoreceptors are anesthetized but muscle spindles are not anesthetized, and tendons are again vibrated mechanically under the conditions that cutaneous mechanoreceptors are inhibited.
The experiment is conducted once or twice per each subject, and if a subject joins the experiment twice, an interval from a week to a month is taken between each experiments. Injection of anesthesic agent is restricted to once at a experiment.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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 To have been injected anesthetics and have neither had an allergic nor anaphylactic reactions
Key exclusion criteria -Having a disease or disorder of motor function of the upper limb
-To have experienced allergic and/or anaphylactic reactions by the injection of local anesthetics
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiko Mabuchi
Organization Graduate School of Information Science and Technology,
The University of Tokyo
Division name Dept. Information Physics and Computing, Graduate School of Information Science and Technology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8656 Japan
TEL 03-5841-6880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiko Mabuchi
Organization Graduate School of Information Science and Technology, The University of Tokyo
Division name Dept. Information Physics and Computing, Graduate School of Information Science and Technology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8656 Japan
TEL 03-5841-6880
Homepage URL
Email Kunihiko_Mabuchi@ipc.i.u-tokyo.ac.jp

Sponsor
Institute 7th Laboratory, Department of Information Physics and Computing, Graduate School of Information Science and Technology, The University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) Ministry of Health Labour and Welfare

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 10 Month 01 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 Completed
Date of protocol fixation
2009 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 07 Day
Last modified on
2010 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003016

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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