UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032481 |
|---|---|
| Receipt number | R000037032 |
| Scientific Title | Myoelectric/Functional hand for traumatic amputees |
| Date of disclosure of the study information | 2018/05/06 |
| Last modified on | 2019/05/19 16:47:42 |
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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
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
ttkg7@me.com
Public contact
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
ttkg7@me.com
Sponsor or person
Institute
Tokai 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037032
