UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057435 |
|---|---|
| Receipt number | R000065627 |
| Scientific Title | Effect of Unilateral Lower Limb Unstable Platform Task with Cervical Electrical Stimulation on Postural Control in Healthy Individuals: Investigation of Cerebral Blood Flow and Trunk Muscle Activity |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/03/28 15:17:11 |
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Basic information
Public title
Effect of Unilateral Lower Limb Unstable Platform Task with Cervical Electrical Stimulation on Postural Control in Healthy Individuals: Investigation of Cerebral Blood Flow and Trunk Muscle Activity
Acronym
Effect of Unilateral Lower Limb Unstable Platform Task with Cervical Electrical Stimulation on Postural Control in Healthy Individuals
Scientific Title
Effect of Unilateral Lower Limb Unstable Platform Task with Cervical Electrical Stimulation on Postural Control in Healthy Individuals: Investigation of Cerebral Blood Flow and Trunk Muscle Activity
Scientific Title:Acronym
Effect of Unilateral Lower Limb Unstable Platform Task with Cervical Electrical Stimulation on Postural Control in Healthy Individuals
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the effects of cervical muscle stimulation using TENS during a unilateral lower limb unstable platform task on trunk muscle activity and cerebral blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow and electromyography will be measured before, during, immediately after, and five minutes after the task.
Key secondary outcomes
Body sway before the task, during the task, while the child was performing the task, and 5 minutes after the task
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control Group
After maintaining a quiet standing posture for 30 seconds, participants perform a lateral weight-shifting task at 0.5 Hz for 30 seconds, followed by another 30 seconds of quiet standing. This sequence is considered one set and is repeated three times.Unstable Platform Group
Participants stand with their dominant foot on an unstable platform and their non-dominant foot on a platform of equal height (Figure 2). Following the same protocol as the control group, they maintain a quiet standing posture for 30 seconds, perform a lateral weight-shifting task at 0.5 Hz for 30 seconds, and then return to quiet standing for another 30 seconds. This sequence is repeated three times.
Interventions/Control_2
Unstable board Group
Participants stand with their dominant foot on an unstable platform and their non-dominant foot on a platform of equal height (Figure 2). Following the same protocol as the control group, they maintain a quiet standing posture for 30 seconds, perform a lateral weight-shifting task at 0.5 Hz for 30 seconds, and then return to quiet standing for another 30 seconds. This sequence is repeated three times.
Interventions/Control_3
Unstable board + TENS Group (Combined Group)
Participants follow the same protocol as the other groups: 30 seconds of quiet standing, 30 seconds of lateral weight shifting at 0.5 Hz, and another 30 seconds of quiet standing, repeated for three sets. However, during the task, TENS stimulation is applied to the left sternocleidomastoid muscle (Figure 3). The TENS parameters are set to a frequency of 100 Hz, a pulse width of 200 microseconds, and an intensity above the sensory threshold but below the motor threshold.
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
| 34 | years-old | >= |
Gender
Male
Key inclusion criteria
Right-foot-dominant individuals aged 20 to 34 years.
Key exclusion criteria
Individuals with a history of lower limb fractures, low back pain, neurological disorders, diabetes, or vestibular disorders, as well as those with neck pain or neck-related conditions.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Nagai |
Organization
Tokyo Metropolitan University Graduate School of Health Sciences
Division name
Department of Physical Therapy Science
Zip code
116-0012
Address
7-2-10 Higashi-Oku, Arakawa-ku, Tokyo
TEL
03-3819-1211
baseballer.k.n891106@gmail.com
Public contact
Name of contact person
| 1st name | Secretariat |
| Middle name | |
| Last name | Arakawa Campus Research Ethics Committee |
Organization
Arakawa Campus Research Ethics Committee
Division name
Secretariat
Zip code
116-0012
Address
7-2-10 Higashi-Oku, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
a-rinri@jmj.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University Graduate School
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
Arakawa Campus Research Ethics Committee
Address
7-2-10 Higashi-Oku, Arakawa-ku, Tokyo
Tel
03-3819-1211
a-rinri@jmj.tmu.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 | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2027 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065627
