UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026389
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hashida_ryuuki@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.