UMIN-CTR Clinical Trial

Basic information
Public title	Clinical application of a wearable integrated volitional control electrical stimulation device for patient with motor disability in upper extremity at subacute phase.
Acronym	Clinical application of a WIVES device for patient with motor disability in upper extremity at subacute phase.
Scientific Title	Clinical application of a wearable integrated volitional control electrical stimulation device for patient with motor disability in upper extremity at subacute phase.
Scientific Title:Acronym	Clinical application of a WIVES device for patient with motor disability in upper extremity at subacute phase.
Region	Japan

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

Objectives
Narrative objectives1	This study aim to examine the efficacy of wearable integrated volitional control electrical stimulation device for patients with motor disability in upper extremity at subacute phase.
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	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The intervention group attaches a wearable integrated volitional control electrical stimulation device for 6 hours a day, 28 days. The target muscle is extensor digitorum muscle. The patient actively uses paralyzed upper extremity in daily life.Therapy are performed physical therapy, occupational therapy and speech-language-hearing therapy, total 180 minutes a day at most.
Interventions/Control_2	The control group attaches a conventional integrated volitional control electrical stimulation device for 6 hours a day, 28 days. The target muscle is extensor digitorum muscle. The patient actively uses paralyzed upper extremity in daily life.Therapy are performed physical therapy, occupational therapy and speech-language-hearing therapy, total 180 minutes a day at most.
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 motor disability in upper extremity, 2)Those who passed within 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	1st name Yasuo Middle name Last name Mikami
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	602-8566
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	1st name Suzuyo Middle name Last name Ohashi
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	602-8566
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)

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan.
Tel	075-251-5337
Email	rinri@koto.kpu-m.ac.jp

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 04 Month 01 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	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 15 Day
Date of IRB	2019 Year 09 Month 13 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 21 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030533