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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026624
Receipt No. R000030533
Scientific Title Clinical application of a wearable integrated volitional control electrical stimulation device for patient with motor disability in upper extremity at subacute phase.
Date of disclosure of the study information 2017/04/01
Last modified on 2019/03/26

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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
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
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
2019 Year 03 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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