UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026624
Receipt number 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 2020/01/31 11:42:32

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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 or person

Institute

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Value
https://center6.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