UMIN-CTR Clinical Trial

Basic information
Public title	Myoelectric/Functional hand for traumatic amputees
Acronym	Myoelectric/Functional hand for traumatic amputees
Scientific Title	Myoelectric/Functional hand for traumatic amputees
Scientific Title:Acronym	Myoelectric/Functional hand for traumatic amputees
Region	Japan

Condition
Condition	Traumatic amputees of upper extremity
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Traumatic amputees experience difficulties in their daily lives and issues with their appearance. Several reports of toe tranfers or hand transplantation have been reported. However, it is difficult for people to accept the appearance of toe transfers to the hand and to manage immune reactions following transplantation. Therefore, myolectric arms/hands regulated by surface myoelectrogram signals have attracted worldwide attention. Firstly, the patients do rehabilitation with the static cosmetic prosthesis. After that, we introduce myoelectric prosthesis, which controls with the electrical signals generated naturally by remaining muscle, for such patients. We investigate efficacy of myoelectric prosthesis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ADL evaluation using DASH (Disabilities of the Arm, Shoulder and Hand) score
Key secondary outcomes	Functional evaluation (box and block test, pick and place test), Evaluation of remaining muscle using needle EMG/surface EMG

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Applying prosthesis for traumatic amputees of upper extremity, 1 year
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	Traumatic amputees (digit, wrist, forearm, arm) with consents.
Key exclusion criteria	1. Patients with heavy heart, liver, or kidney disease. 2. Pregnant patients. 3. Patients who are improper for the study judged by doctors.
Target sample size	6

Research contact person
Last name of lead principal investigator	1st name Takehiko Middle name Last name Takagi
Organization	Tokai University School of Medicine
Division name	Department of Orthopaedic Surgery, Surgical Science
Zip code	259-1193
Address	143 Shimokasuya, Isehara-shi, Kanagawa 259-1193, Japan
TEL	0463-93-1121
Email	ttkg7@me.com

Public contact
1st name of contact person	1st name Takehiko Middle name Last name Takagi
Organization	Tokai University School of Medicine
Division name	Department of Orthopaedic Surgery, Surgical Science
Zip code	259-1193
Address	143 Shimokasuya, Isehara-shi, Kanagawa 259-1193, Japan
TEL	0463-93-1121
Homepage URL
Email	ttkg7@me.com

Sponsor
Institute	Tokai 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokai University School of Medicine
Address	143 Shimokasuya, Isehara-shi, Kanagawa 259-1193 Japan
Tel	0463-93-1121
Email	ttkg7@me.com

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	2018 Year 05 Month 06 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	4
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	Main results already published
Date of protocol fixation	2015 Year 01 Month 19 Day
Date of IRB	2015 Year 01 Month 19 Day
Anticipated trial start date	2015 Year 01 Month 19 Day
Last follow-up date	2018 Year 09 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	2018 Year 05 Month 06 Day
Last modified on	2019 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037032