UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026389 |
|---|---|
| Receipt number | R000030323 |
| Scientific Title | Study on the Effects of Motor-Assisted Gloves (SEM Glove) on Functional Disorders of Fingers |
| Date of disclosure of the study information | 2017/03/03 |
| Last modified on | 2018/09/03 16:16:59 |
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Basic information
Public title
Study on the Effects of Motor-Assisted Gloves (SEM Glove) on Functional Disorders of Fingers
Acronym
Study on the Effects of Motor-Assisted Gloves (SEM Glove) on Functional Disorders of Fingers
Scientific Title
Study on the Effects of Motor-Assisted Gloves (SEM Glove) on Functional Disorders of Fingers
Scientific Title:Acronym
Study on the Effects of Motor-Assisted Gloves (SEM Glove) on Functional Disorders of Fingers
Region
| Japan |
Condition
Condition
hospitalized patients with upper limb functional disorders or patients receiving treatment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of using SEM glove for long periods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pinch strength,upper extremity function evaluation(ARAT:Action Research Arm Test,STEF:simple test for evaluating hand function)
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Using of the SEM glove for 2 months
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
The patients who are available for an exercise for 10-20 minutes a day
Key exclusion criteria
The patients who had the skin disease that is hard to attach the device.The patients who had the skin disease that is hard to attach the device.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuki Hashida |
Organization
Kurume university orthopedics surgery
Division name
Division of Rehabilitation
Zip code
Address
67 Asahi-machi, Kurume-shi, Fukuoka
TEL
+81-942-31-7568
hashida_ryuuki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuki Hashida |
Organization
Kurume university orthopedics surgery
Division name
Division of Rehabilitation
Zip code
Address
67 Asahi-machi, Kurume-shi, Fukuoka
TEL
+81-942-31-7568
Homepage URL
hashida_ryuuki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
SK-Electronics CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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 | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030323
