UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058736 |
|---|---|
| Receipt number | R000067162 |
| Scientific Title | Effects of Unilateral Vibration Stimulation on Muscle Tone in Contralateral Homologous Muscles in Patients with Post-Stroke Spasticity |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 13:01:58 |
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Basic information
Public title
Effects of Unilateral Vibration Stimulation on Muscle Tone in Contralateral Homologous Muscles in Patients with Post-Stroke Spasticity
Acronym
Unilateral Vibration for Contralateral Spasticity Reduction
Scientific Title
Effects of Unilateral Vibration Stimulation on Muscle Tone in Contralateral Homologous Muscles in Patients with Post-Stroke Spasticity
Scientific Title:Acronym
Unilateral Vibration for Contralateral Spasticity Reduction
Region
| Japan |
Condition
Condition
Stroke patients
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether unilateral vibration stimulation suppresses spasticity during stimulation in patients with post-stroke spasticity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, H-reflexes will be measured from the paretic-side flexor carpi radialis muscle before and during vibratory stimulation. The waveform analysis parameters of the H-reflex will include the average H-wave amplitude and the H/M amplitude ratio.
Key secondary outcomes
In this study, muscle hardness will be measured in addition to the H-reflex.
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
Vibration stimulation generally requires setting the frequency, amplitude, load weight, stimulation site, and stimulation time. In this study, a vibration stimulus with a frequency of 80 Hz, amplitude 0.4 mm, and load weight 400 g for 70 seconds to the FCR on the paralyzed side. A muscle-tendon vibratory stimulation device, MGV-1000-F (Uchida Electron Co., Ltd., Tokyo, Japan), was utilized to apply the 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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were defined as patients with upper limb motor impairment after stroke and a Modified Ashworth Scale (MAS) score of 1 or higher in the flexor carpi radialis muscle.
Key exclusion criteria
Exclusion criteria were as follows: participants with a FCR MAS score of 4, those unable to maintain the starting position of the examination due to joint range of motion limitations, those with upper limb motor disorders not caused by stroke, those with bilateral hemiplegia, those with a Hasegawa Dementia Scale Revised (HDS-R) score of 21 or lower, and those with superficial or deep sensory loss.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate School of Kansai University of Health Sciences
Division name
Graduate School of Health Sciences
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori-cho, Sennen-gun, Osaka, Japan
TEL
+81-(0)72-453-8251
suzuki@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Kunoh |
Organization
Yamada Hospital
Division name
Department of rehabilitation
Zip code
5010104
Address
7-110 Terada, Gifu City, Gifu Prefecture, Japan
TEL
+81-58-254-1411
Homepage URL
shotwinbaseball0624@gmail.com
Sponsor or person
Institute
Graduate School of Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Kansai University of Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennen-gun, Osaka, Japan
Tel
+81-(0)72-453-8251
24d002@kuhs-m.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 | 08 | Month | 08 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2025 | 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 | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067162
