UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical application of a wearable integrated volitional control electrical stimulation device for chronic patients with motor disability in upper extremity.
Title of the study (Brief title)	Clinical application of a WIVES device for chronic patients with motor disability in upper extremity.
Region	Japan

Condition
Condition	Stroke, Traumatic brain injury, spinal cord injury, peripheral nerve injury
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim to examine the efficacy of a wearable integrated volitional control electrical stimulation device for chronic patients with motor disability in upper extremity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer assessment score for upper extremity
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The intervention is to attach a wearable integrated volitional control electrical stimulation device at home for 6 hours a day, 28 days. The target muscle is extensor digitorum muscle. The patient actively uses paralyzed upper extremity in daily life and performs exercise for upper extremity.
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	Inclusion criteria is as following: 1) the patient with upper limb paralysis. 2) Those who passed more than 180 days since onset. 3) It is possible to detect the electromyogram of finger extension using the integrated volitional control electrical stimulation device.
Key exclusion criteria	Exclusion criteria is as following: 1) severe limited range of motion in wrist, 2) severe sensory disturbance , 3) severe higher brain dysfunction, 4) patients with the contraindication of electrical stimulation therapy (Cardiovascular disease, Inserting a metal into the body like a pace maker, Infection, Abnormal blood pressure, Parts of abnormal skin, acute disease, Blood flow disturbance)
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuo Mikami
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Rehabilitation Medicine
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL	075-251-5324
Email	reha@koto.kpu-m.ac.jp

Public contact
Name of contact person	Norihide Itoh
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Advanced Rehabilitation Medicine
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL	075-251-5324
Homepage URL
Email	reha@koto.kpu-m.ac.jp

Sponsor
Institute	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 03 Month 21 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030544