UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052760 |
|---|---|
| Receipt number | R000060197 |
| Scientific Title | The Effects of Transcranial Static Magnetic Stimulation over Visual Cortex on Chronic Ankle Instability |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2023/11/30 11:55:37 |
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Basic information
Public title
The Effects of Neuromodulation over Visual Cortex on Chronic Ankle Instability
Acronym
The Effects of Neuromodulation over Visual Cortex on Chronic Ankle Instability
Scientific Title
The Effects of Transcranial Static Magnetic Stimulation over Visual Cortex on Chronic Ankle Instability
Scientific Title:Acronym
The Effects of Transcranial Static Magnetic Stimulation over Visual Cortex on Chronic Ankle Instability
Region
| Japan |
Condition
Condition
Chronic Ankle Instability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tracscranial static magnetic stimulation over the visual cortex on sensory reweighting system, central nervous system function, and residual symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensory reweighting during postural control
Static balance control
Dynamic balance control
Alpha power over the visual cortex
Key secondary outcomes
Survey of Previous Injuries
Subjective ankle instability scale
Functional ankle instability scale
Health-related quality of life
Well being scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Applying transcranial static magnetic stimulation over the visual cortex (30 minutes)
Interventions/Control_2
Applying transcranial static magnetic stimulation over the visual cortex (30 minutes per session, 10 sessions in 4 weeks)
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) A history of at least one severe ankle sprain resulting in unloading, immobilization, or abnormal walking.
2) A history of ankle sprain within the past three months prior to the experiment.
3) A history of at least two ankle sprains.
4) Individuals who have experienced two or more ankle twists within the past six months (not as severe as a sprain, but a momentary "giving way" sensation with immediate pain relief).
5) Individuals who subjectively perceive ankle instability: meeting the criteria of scoring 24 or below on the Cumberland Ankle Instability Tool (CAIT) and scoring 11 or above on the Identification of Functional Ankle Instability.
If the research participants have CAI in both ankles, the subjective assessment of ankle function will be evaluated using a measure called the Foot and Ankle Ability Measure. The lower scoring ankle will be designated as the experimental limb.
Key exclusion criteria
1) Individuals with a history of lower limb fractures or surgeries, excluding ankle sprains, and with significant musculoskeletal injuries.
2) Individuals with a history of concussion.
3) Individuals with liver, kidney, heart diseases, respiratory disorders, endocrine disorders, metabolic disorders, neurological disorders, consciousness disorders, vestibular dysfunction, cardiovascular diseases, diabetes (as defined by the criteria of the Japan Diabetes Society), or other conditions (such as reflex impairment of peripheral blood vessels, acute inflammatory conditions, skin disorders, presence of infectious foci, malignant tumors) that make participation in the study difficult.
4) Individuals who have sustained lower limb injuries within the three months prior to the start of the experiment.
5) Individuals who do not consent to the purpose of the study as explained in the pre-trial briefing.
6) Individuals with non-removable magnetic objects in the head, including artificial inner ear devices, prosthetics, or clips.
7) Individuals with pacemakers and defibrillators implanted in the heart.
8) Individuals with metal allergies.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Terada |
Organization
Ritsumeikan University
Division name
Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga, Japan.
TEL
0775612710
mterada@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Nonoyama |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga, Japan.
TEL
080-4307-1777
Homepage URL
sh0181ek@ed.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Ritsumeikan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Public Interest Incorporated Foundation, Tobe Maki Foundation
Public Interest Incorporated Foundation, Yamaha Motor Foundation for Sports
IRB Contact (For public release)
Organization
Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu, Shiga, Japan.
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2023 | Year | 11 | Month | 13 | 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
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060197
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| Registered date | File name |
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