UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060706 |
|---|---|
| Receipt number | R000069449 |
| Scientific Title | Effect of short-duration palmar vibration on facilitation of wrist and finger motor function in patients with stroke |
| Date of disclosure of the study information | 2026/02/19 |
| Last modified on | 2026/02/19 18:26:13 |
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Basic information
Public title
Effects of short-duration vibration of the palm on hand motor function and electromyographic activity in patients with subacute stroke: A preliminary study
Acronym
Effects of short-duration vibration of the palm on hand motor function and electromyographic activity in patients with subacute stroke: A preliminary study
Scientific Title
Effect of short-duration palmar vibration on facilitation of wrist and finger motor function in patients with stroke
Scientific Title:Acronym
Effect of short-duration palmar vibration on facilitation of wrist and finger motor function in patients with stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this study preliminarily investigated the effects of short-duration palmar vibration on spastic paretic upper limbs in patients with subacute stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Ashworth scale
Key secondary outcomes
range of motion
maximal voluntary isometric contraction
electromyography
box and block test
global impression of change scale
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
| Other |
Interventions/Control_1
vibration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemiparesis due to a single, unilateral stroke; and presence of at least one positive sign of upper motor neuron syndrome (e.g., exaggerated tendon jerks, spasticity, co-contraction, associated reactions, increased flexor reflexes, dystonia, or stiffness).
Key exclusion criteria
(1) presence of significant joint pathologies, such as a history of joint surgery or rheumatoid arthritis; (2) severe sensory impairment; and (3) inability to follow simple commands.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miyara |
| Middle name | |
| Last name | Kodai |
Organization
Kyushu University of Nursing and Social Welfare
Division name
Department of Rehabilitation
Zip code
865-0062
Address
888 Tomino, Tamana, Kumamoto
TEL
0968-75-1800
k-miyara@kyushu-ns.ac.jp
Public contact
Name of contact person
| 1st name | Miyara |
| Middle name | |
| Last name | Kodai |
Organization
Kyushu University of Nursing and Social Welfare
Division name
Department of Rehabilitation
Zip code
865-0062
Address
888 Tomino, Tamana, Kumamoto
TEL
0968-75-1800
Homepage URL
k-miyara@kyushu-ns.ac.jp
Sponsor or person
Institute
Kyushu University of Nursing and Social Welfare
Institute
Department
Personal name
Kodai Miyara
Funding Source
Organization
Kyushu University of Nursing and Social Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hakujyuji Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakujyuji Rehabilitation Hospital
Address
3-3-9 Ishimaru, Nishi-ku, Fukuoka-shi, Fukuoka
Tel
092-891-2611
k-miyara@kyushu-ns.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
白十字リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 19 | 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
20
Results
The results are not yet available as the manuscript is currently being prepared for submission to a peer-reviewed academic journal.
Results date posted
| 2026 | Year | 02 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The results are not yet available as the manuscript is currently being prepared for submission to a peer-reviewed academic journal.
Date of the first journal publication of results
| 2027 | Year | 02 | Month | 19 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 19 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069449
