UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055359 |
|---|---|
| Receipt number | R000063269 |
| Scientific Title | Effects of local vibration stimulation during postural control tasks |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/04/19 10:19:51 |
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Basic information
Public title
Effects of local vibration stimulation during postural control tasks
Acronym
Effects of local vibration stimulation during postural control tasks
Scientific Title
Effects of local vibration stimulation during postural control tasks
Scientific Title:Acronym
Effects of local vibration stimulation during postural control tasks
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The posture is controlled by the processing and integration of equilibrium information from visual, vestibular, and proprioceptive sensory inputs, which are coordinated by the brainstem, cerebellum, and basal ganglia.However, when the intrinsic sensory function is impaired, the coordination between the nerves and motor units is disrupted, and the mechanisms involved in maintaining standing posture are greatly affected.Therefore, the importance of the influence of many joints involved in the standing posture has been studied.In dynamic standing posture control, afferent signals from plantar sensation and muscle spindles of the lower leg muscles play an important role in postural control.Some previous studies have suggested that local vibration stimulation of the lower leg muscles in the standing posture may induce firing activity of muscle spindles, leading to improvement of proprioception through activation of the cerebral cortex.Previous studies have shown that stroke patients are compensated for postural control by vision due to disruption of equilibrium sensory information caused by motor paralysis and eigensensensory dysfunction.In clinical practice, we aim to improve the balance ability of patients who have broken free from this excessive visual compensation, to improve their eigensensensory impairment, and to re-establish postural control.Many previous studies on the effects of vibration stimulation have reported that vibration stimulation activates Ia afferent fibers, which are eigensensensory receptors.The purpose of this study is to investigate the effect of local vibration stimulation on the gastrocnemius muscle during a postural control task in healthy subjects by comparing the performance ratio of the postural control task, observing muscle activity and center of gravity sway during postural control, and examining the effectiveness of changes in intrinsic sensory information during balance training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posture control task execution error (performance ratio)
Key secondary outcomes
Surface electromyography, center-of-gravity sway testing
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
Tracking task: A red point moving in a straight line and the subject's center of gravity are projected on a monitor in front of the subject. 10 seconds after the red point moves back and forth, the subject performs a center-of-gravity manipulation task with his/her foot so that his/her center of gravity is superimposed on the red point.Measurement limb position: The lower limb not to be measured is placed on a 20 cm platform, and the lower limb to be measured is placed at the center of the sokinetic scale.The patient is placed in a pseudo-one-leg standing position.Vibration stimulation: A small vibration testing device (Wave Maker01: Asahi Mfg. Co., Ltd.) is used, with a frequency of 100 Hz and an amplitude range of 1.2 mmp-p applied to the medial head of the gastrocnemius muscle.The pressure applied to the contact surface is constantly monitored by using a pressure sensor to indicate on a monitor that the contact pressure to the skin surface is constant.During the experiment, the subject is secured with a belt so that the point of vibration does not change.To eliminate as much as possible any learning effect on the task, the participants practiced the tracking task 40 times prior to the start of the experiment.Measurements were taken in 10 sets of 10 seconds without the vibration stimulus, 10 sets of 10 seconds with the vibration stimulus as the intervention condition, and 10 sets of 10 seconds without the vibration stimulus.
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participant must be able to understand the instructions for the precise center-of-gravity manipulation task experiment and give his/her consent to participate in the experiment.
Key exclusion criteria
The participant must be unable to perform the posture control tasks in the experiment due to injury or other reasons.In case of injury, the participant may participate in the experiment after healing.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Imamura |
Organization
Kanagawa Prefectural University of Health and Welfare
Division name
Rehabilitation area of Health and Welfare Studies
Zip code
2388522
Address
1-10-1, Heisei-cho, Yokosuka, Kanagawa, Japan
TEL
0468282500
adl.cruijff14@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Imamura |
Organization
Kanagawa Prefectural University of Health and Welfare
Division name
Rehabilitation area of Health and Welfare Studies
Zip code
2388522
Address
1-10-1, Heisei-cho, Yokosuka, Kanagawa, Japan
TEL
0468282500
Homepage URL
adl.cruijff14@gmail.com
Sponsor or person
Institute
Kanagawa Prefectural University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefectural University of Health and Welfare
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
Kanagawa University of Health and Welfare
Address
1-10-1, Heisei-cho, Yokosuka, Kanagawa, Japan
Tel
0468282500
adl.cruijff14@gmail.com
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
| 2024 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063269
