UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the Effects of Motor-Assisted Gloves (SEM Glove) on Functional Disorders of Fingers
Title of the study (Brief title)	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	Ryuki Hashida
Organization	Kurume university orthopedics surgery
Division name	Division of Rehabilitation
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	Ryuki Hashida
Organization	Kurume university orthopedics surgery
Division name	Division of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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