UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033681