UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057967 |
|---|---|
| Receipt number | R000066273 |
| Scientific Title | Effect of Short-term Palmar Vibration Stimulation on Wrist Movement in Stroke Patients |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/26 14:37:13 |
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Basic information
Public title
Effect of Short-term Palmar Vibration Stimulation on Wrist Movement in Stroke Patients
Acronym
Effect of Palmar Vibration on Wrist movement in Stroke Patients
Scientific Title
Effect of Short-term Palmar Vibration Stimulation on Wrist Movement in Stroke Patients
Scientific Title:Acronym
Effect of Palmar Vibration on Wrist movement in Stroke Patients
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
his study aims to investigate the effect of short-term palmar vibration stimulation on wrist movement in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyographic analysis
Key secondary outcomes
Kinematic analysis
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
vibratory stimulation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1. Patients with central nervous system disorders (e.g., stroke, spinal cord injury).
2. Patients with upper limb paralysis in the acute to chronic phase.
3. Inpatients or outpatients of the Department of Rehabilitation, Kagoshima University Hospital.
Healthy participant
1. Healthy adult volunteers without central nervous system disorders
Key exclusion criteria
1. Individuals for whom participation is deemed difficult due to mental status.
2. Patients with metal near the head (e.g., cochlear implants, magnetic clips, deep brain stimulators, vagus nerve stimulators) or with cardiac pacemakers.
3. Other cases judged ineligible by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hoei |
Organization
kagoshima univercity hospital
Division name
Division of rehabilitation
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
TEL
099-275-5111
k8877352@kadai.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hoei |
Organization
Kagoshima univercity hospital
Division name
Division of rehabilitation
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
TEL
099-275-5111
Homepage URL
k8877352@kadai.jp
Sponsor or person
Institute
Kagohima univercity
Institute
Department
Personal name
Funding Source
Organization
other
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
Kagoshima univercity hospital
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
Tel
099-275-6624
crmc@m2.kufm.kagoshima-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
| 2025 | Year | 05 | Month | 26 | 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 | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | 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
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066273
