UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029479
Receipt No. R000033681
Scientific Title Short-term effect of novel prosthesis for auditory feedback during gait using prosthetic limb
Date of disclosure of the study information 2017/10/17
Last modified on 2017/10/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Short-term effect of novel prosthesis for auditory feedback during gait using prosthetic limb
Acronym Effect of novel prosthesis for auditory feedback
Scientific Title Short-term effect of novel prosthesis for auditory feedback during gait using prosthetic limb
Scientific Title:Acronym Effect of novel prosthesis for auditory feedback
Region
Japan

Condition
Condition Healthy controls
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to examine an effect of the prothesis for auditory feedback on gait in healthy controls who loses plantar sensory because of attatching a prosthetic limb.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes spatial and temporal parameters
kinematic parameter
kinetic parameter
Key secondary outcomes joint stiffness
whole body angular momentum

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Subject who wears a prosthesis leg walks on 7m walking path.
Interventions/Control_2 Subject who wears a prosthesis leg walks on 7m walking path using prosthesis for auditory feedback.
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 the participantes approves participation tothe present study
Key exclusion criteria Subjects are excluded if they had any of the following: cerebroneuropathy, dementia, and orthopedic diseases.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-Ichi Izumi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address 2-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
TEL 022-717-7338
Email izumis@bme.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Sekiguchi
Organization Tohoku University Hospital
Division name Department of Rehabilitation
Zip code
Address 1-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
TEL 022-717-7677
Homepage URL
Email yusuke.sekiguchi.b2@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Neuro-Robotics Lab. (Hayashibe Lab.)
Dept. of Robotics, Graduate School of Engineering, Tohoku University
IoT Devices Research Laboratories, NEC Co
Name of secondary funder(s) IoT Devices Research Laboratories, NEC Co

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
2017 Year 10 Month 17 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
2017 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 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
2017 Year 10 Month 10 Day
Last modified on
2017 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.