Unique ID issued by UMIN | UMIN000026624 |
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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 |
Clinical application of a wearable integrated volitional control electrical stimulation device for patient with motor disability in upper extremity at subacute phase.
Clinical application of a WIVES device for patient with motor disability in upper extremity at subacute phase.
Clinical application of a wearable integrated volitional control electrical stimulation device for patient with motor disability in upper extremity at subacute phase.
Clinical application of a WIVES device for patient with motor disability in upper extremity at subacute phase.
Japan |
Stroke, Traumatic brain injury, spinal cord injury, peripheral nerve injury
Clinical immunology | Rehabilitation medicine |
Others
NO
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.
Efficacy
Fugl-Meyer assessment score for upper extremity
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Device,equipment |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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)
30
1st name | Yasuo |
Middle name | |
Last name | Mikami |
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Department of Rehabilitation Medicine
602-8566
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
075-251-5324
reha@koto.kpu-m.ac.jp
1st name | Suzuyo |
Middle name | |
Last name | Ohashi |
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Department of Rehabilitation Medicine
602-8566
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
075-251-5324
reha@koto.kpu-m.ac.jp
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
None
Self funding
Kyoto Prefectural University of Medicine, Clinical Research Review Board
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan.
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
2017 | Year | 04 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 09 | Month | 15 | Day |
2019 | Year | 09 | Month | 13 | Day |
2017 | Year | 04 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 21 | Day |
2020 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030533
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