UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059248 |
|---|---|
| Receipt number | R000067768 |
| Scientific Title | A Study on the Suppression of Spasticity by Vibration Stimulation |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/30 20:19:04 |
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Basic information
Public title
A Study on the Suppression of Spasticity by Vibration Stimulation
Acronym
A Study on the Suppression of Spasticity by Vibration Stimulation
Scientific Title
A Study on the Suppression of Spasticity by Vibration Stimulation
Scientific Title:Acronym
A Study on the Suppression of Spasticity by Vibration Stimulation
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Spasticity is defined as a velocity-dependent increase in muscle tone accompanied by hyperreflexia. Clinical findings include increased resistance during passive movement, hyperreflexia, and clonus. Spasticity is observed in many patients after cerebrovascular disorders and impedes activities of daily living, making appropriate spasticity assessment and treatment crucial. Vibration stimulation is one treatment for spasticity, with numerous reports on its efficacy. However, there is no consensus on optimal conditions such as frequency, amplitude, or duration of vibration stimulation. It is necessary to clarify effective stimulation conditions within a short timeframe.Many reports use the Modified Ashworth Scale (MAS) to assess the effectiveness of vibration stimulation, which involves judging the resistance felt when manually moving the target joint on a 6-point scale. However, the MAS procedure is ambiguous, and the low reliability of MAS evaluation results is a concern. Quantitative evaluation is necessary to appropriately assess spasticity and clarify treatment effects.The purpose of this study is to use quantitative evaluation to analyze in detail the spasticity-suppressing effects of vibration stimulation and to clarify the optimal stimulation settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Joint resistance torque during passive ankle dorsiflexion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects capable of undergoing three-dimensional motion analysis and the 10m walking test shall undergo these gait assessments.
Measure the subject's maximum ankle dorsiflexion angle.
Position the subject in a reclining wheelchair and ensure they remain at rest.
The subject's posture shall be set with the hip joint at 45 degrees of flexion and the knee joint at 60 degrees of flexion.
Attach the iQMoS to the subject's foot.
Using the spasticity measurement device, move the subject's ankle joint twice each at low speed (5 degrees/second) and high speed (300degrees/second) up to the maximum dorsiflexion angle measured in step 1.
Remove the spasticity measurement device.
Condition 1: Apply low-frequency (30Hz), high-amplitude (2-4mm) vibration stimulation using the Power Plate pro5.
Immediately after vibration stimulation, repeat steps 1 through 6.
Subsequently, repeat steps 1 through 6 to confirm the duration of effect.
Interventions/Control_2
Subjects capable of undergoing three-dimensional motion analysis and the 10m walking test shall undergo these gait assessments.
Measure the subject's maximum ankle dorsiflexion angle.
Position the subject in a reclining wheelchair and ensure they remain at rest.
The subject's posture shall be set with the hip joint at 45 degrees of flexion and the knee joint at 60 degrees of flexion.
Attach the iQMoS to the subject's foot.
Using the spasticity measurement device, move the subject's ankle joint twice each at low speed (5 degrees/second) and high speed (300degrees/second) up to the maximum dorsiflexion angle measured in step 1.
Remove the spasticity measurement device.
Apply low-frequency (91Hz) vibration stimulation with an amplitude of 1.0mm using the Handheld Massager MD-001S
Immediately after vibration stimulation, repeat steps 1 through 6.
Subsequently, repeat steps 1 through 6 to confirm the duration of effect.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who, after receiving full explanation and with full understanding, provided written consent of their own free will to participate in this study
Individuals diagnosed with central nervous system disorders
Key exclusion criteria
Individuals with unstable general condition
Individuals unable to understand instructions due to impaired consciousness or severe aphasia
Individuals with a history of orthopedic disorders in the ankle joint
Individuals with passive ankle dorsiflexion range of motion less than 0 degrees
Individuals deemed inappropriate by the principal investigator or co-investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
4701192
Address
1-98, Danrakegakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture
TEL
0562-93-2111
otaka119@me.com
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Ito |
Organization
Fujita Health University Hospital
Division name
Rehabilitation Department
Zip code
4701192
Address
1-98, Danrakegakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture
TEL
0562-93-2111
Homepage URL
toshiki.ito@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Fujita Health University Hospital
Address
1-98, Danrakegakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture
Tel
0562-93-2111
toshiki.ito@fujita-hu.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 | 09 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 05 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067768
