UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058764 |
|---|---|
| Receipt number | R000067192 |
| Scientific Title | Clinical Evaluation of a Wearable Volitional Movement-Assist Electrical Stimulation Device in Patients with Upper Limb Motor Paralysis |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/02/01 14:16:04 |
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Basic information
Public title
Effect of Electrical Stimulation Device for Upper Limb Paralysis
Acronym
Effect of Electrical Stimulation Device for Upper Limb Paralysis
Scientific Title
Clinical Evaluation of a Wearable Volitional Movement-Assist Electrical Stimulation Device in Patients with Upper Limb Motor Paralysis
Scientific Title:Acronym
W-VMAF Study (Wearable Volitional Movement-Assist FES Study)
Region
| Japan |
Condition
Condition
Upper limb paralysis caused by central nervous system diseases such as stroke (cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage), head injury, cervical spinal cord injury, cervical spondylotic myelopathy, and syringomyelia
Classification by specialty
| Neurology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate upper limb use and improvement in voluntary movement in daily life situations using a Wearable Integrated Volitional control Electrical Stimulation (WIVES) device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment (Upper Extremity section)
Key secondary outcomes
MAL, WMFT, ARAT, MAS, device wearing time and usability evaluation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age >= 20 years at the time of consent.
2.No restriction on sex.
Key exclusion criteria
1. Patients who were unable to complete the self-directed training program.
2. Patients with missing outcome assessments.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koshiro |
| Middle name | |
| Last name | Sawada |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kawaramachi-dori, Hirokoji-agaru, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5324
koshiro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Norikazu |
| Middle name | |
| Last name | Hishikawa |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kawaramachi-dori, Hirokoji-agaru, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5324
Homepage URL
hisikawa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
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, Institutional Review Board
Address
465 Kawaramachi-dori, Hirokoji-agaru, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
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
| 2026 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067192
