UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057617 |
|---|---|
| Receipt number | R000065450 |
| Scientific Title | The effect of electroacupuncture on Time to Stabilization in chronic ankle instability. |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/04/15 13:50:15 |
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Basic information
Public title
The effect of electroacupuncture on Time to Stabilization in chronic ankle instability.
Acronym
The effect of electroacupuncture on Time to Stabilization in chronic ankle instability.
Scientific Title
The effect of electroacupuncture on Time to Stabilization in chronic ankle instability.
Scientific Title:Acronym
The effect of electroacupuncture on Time to Stabilization in chronic ankle instability.
Region
| Japan |
Condition
Condition
Chronic Ankle Instability
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of acupuncture on postural stabilization time after landing on a single-leg drop jump landing. The significance of this study is that not only the incidence of ankle sprains during sports activities is high, but also the sprains are likely to be shifted to CAI. FAI is reported to cause a decrease in the ability to control posture. Recently, TTS has been focused as one of the evaluation methods for postural control ability. It is assumed that the shortening of postural stabilization time by acupuncture improves postural control ability and decreases ankle instability, which may contribute to the prevention of ankle sprains. Compared to the evaluation items used in previous studies, this study will use a single-leg drop-jump landing, which is an exercise task similar to a sports activities, and thus may be applicable to the sports field.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The primary outcome of this study is the postural stabilization time of 20 seconds after single-leg drop jump landing. The postural stabilization time is the time required for the posture to stabilize, and is calculated using the floor reaction force components in the left and right directions after landing a one-leg drop jump. The postural stabilization time will be evaluated by measuring the postural stabilization time before and after the acupuncture or control.
Key secondary outcomes
The first secondary outcome of the present study is the center-of-gravity sway during 5 seconds after landing a one-leg drop-jump. In this study, the center of gravity sway is evaluated by the total trajectory length, which represents the total distance traveled by the center of plantar pressure. Since the force plate and TRIAS used in this study can also measure the center of gravity sway from the floor reaction force component, the postural stabilization time and the total trajectory length will be measured simultaneously from one trial. The time of evaluation will be assessed by measuring the total trajectory length before and after intervention and rest holding. The second secondary outcome of this study is the measurement of ankle instability during the landing of a one-leg drop jump. This Visual Analogue Scale will be administered twice at the end of each drop-jump landing, before and after acupuncture stimulation or rest holding. The subjects are asked to fill in the 100 mm line from the left to the right, with 0 mm being no instability at all and 100 mm being the strongest instability imaginable.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
(1) Electroacupuncture group Phase 1 will include 7 interventions out of a total of 14 measurements spaced at least 1 week apart. Phase 2 will include 1 intervention out of a total of 2 measurements spaced at least 1 week apart. The electroacupuncture stimulation is performed using completely sterile, single-use disposable stainless steel needles (Seirin:40 mm in length and 0.2 mm in diameter) after thorough disinfection of the hands and treatment area. The acupuncture needle should be placed in the peroneus shortus muscle on the affected side. The depth of penetration should be just enough to reach the muscle(approximately 2 cm). The stimulation frequency is 1 Hz, the stimulation duration is 10 minutes,and the stimulation intensity is sufficient to induce muscle contraction. A picorina (Seirin, electro-acupuncture pole low-frequency treatment device) will be used for the electro-acupuncture stimulation. Participants will be placed in a supine position on the bed with the affected side of the body facing upward,and will be kept awake and at rest during the acupuncture stimulation.
Interventions/Control_2
(2) Control group Phase 1 will include 7 interventions out of a total of 14 measurements spaced at least 1 week apart. Phase 2 will include 1 intervention out of a total of 2 measurements spaced at least 1 week apart . Participants will be placed in the same position as in the acupuncture group, lying on their side on the bed with the affected side upward, and will be kept awake and at rest. In order to match the acupuncture group, the resting period will be 15 minutes, taking into account the time required for the treatment and preparation time.
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
Phase 1: 1 adult with FAI Phase 2: 12 adults with FAI.
1) Inclusion Criteria
(1) History of at least one severe ankle sprain. (The first sprain must have occurred at least 1 year prior to study enrollment and must have been accompanied by inflammatory symptoms that limited desired physical activity for at least 1 day)
(2)Giving way: a sensation of twisting or instability of the ankle in daily life or during exercise.
(3)Identification of Functional Ankle Instability-J (hereafter: IdFAI-J) score of 11 or more (IdFAI-J: Functional Ankle Instability Questionnaire Japanese version)
Key exclusion criteria
(1) History of musculoskeletal surgery or fracture of the lower extremity
(2) Trauma to the lower extremity within the past 3 months that resulted in the cessation of physical activity for at least 1 day.
(3)Has vestibular or neurological dysfunction.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Yorimoto |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Graduate School of Health Care Medicine MST Division Pre-Doctoral Program
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo
TEL
03-6730-7000
5124004@tau.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Yorimoto |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Graduate School of Health Care Medicine MST Division Pre-Doctoral Program
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo
TEL
03-6730-7000
Homepage URL
514004@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical and Health Science
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
Tokyo Ariake University of Medical and Health Science
Address
2-9-1 Ariake, Koto-ku, Tokyo
Tel
03-6730-7000
514004@tau.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 | 05 | Month | 01 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 29 | 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
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065450
