UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061853 |
|---|---|
| Receipt number | R000070775 |
| Scientific Title | Feasibility of upper limb electrical stimulation rehabilitation triggered by motor imagery: An exploratory single-arm study |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/10 02:34:17 |
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Basic information
Public title
Feasibility of upper limb electrical stimulation rehabilitation triggered by motor imagery: An exploratory single-arm study
Acronym
Feasibility of upper limb electrical stimulation rehabilitation triggered by motor imagery: An exploratory single-arm study
Scientific Title
Feasibility of upper limb electrical stimulation rehabilitation triggered by motor imagery: An exploratory single-arm study
Scientific Title:Acronym
Feasibility of upper limb electrical stimulation rehabilitation triggered by motor imagery: An exploratory single-arm study
Region
| Japan |
Condition
Condition
Upper limb paresis due to stroke, neurotrauma, or spinal cord injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and effectiveness of rehabilitation using a motor-imagery-triggered neuromodulation device (WILMO) in patients with upper limb paresis, and to elucidate the underlying neurophysiological mechanisms during the functional recovery process.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum grip strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Both the "with-intervention" condition (using the wilmo wearable voluntary movement-assisted electrical stimulation device) and the "without-intervention" condition (voluntary movement only) are performed within the same day in a randomized order.
With-intervention condition: After measuring maximum grip strength, patients perform 30 repetitions of gripping exercises at 15% load, where muscle contraction is induced by WILMO triggered by motor-intention-related EEG changes (approx. 10 min).
Without-intervention condition: After measuring maximum grip strength, patients perform 30 repetitions of the same gripping exercises using voluntary effort only (approx. 10 min).
A 15-to-20-minute rest period (washout) is provided between the two conditions to allow recovery from fatigue.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stroke, neurotrauma, or spinal cord injury admitted to the Department of Neurology or Department of Neurosurgery at Kyoto University Hospital.
Patients presenting with upper limb paresis graded from 0/5 to 4/5 on the Manual Muscle Test (MMT).
Patients aged between 18 and 75 years.
Patients who can fully understand the study explanation and provide written informed consent.
Key exclusion criteria
Patients with impaired consciousness (Japan Coma Scale score of 2 digits or higher) who cannot understand explanations or instructions.
Patients with dementia who cannot understand explanations or instructions.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Sawada |
Organization
Kyoto University Hospital
Division name
Department of Neurosurgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3111
sawadaphoto6@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Sawada |
Organization
Kyoto University Hospital
Division name
Department of Neurosurgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3111
Homepage URL
sawadaphoto6@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
kYOTO UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kyoto University Hospital
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-751-4899
osb-ethic@kuhp.kyoto-u.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 | 06 | Month | 10 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070775
