UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029479 |
|---|---|
| Receipt number | 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 | 2019/10/25 20:32:48 |
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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
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
yusuke.sekiguchi.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 30 | Day |
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
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033681
