UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061946 |
|---|---|
| Receipt number | R000070879 |
| Scientific Title | Functional Deficits of the Peroneus Longus and Brevis Muscles and Compensatory Strategies in Individuals with Chronic Ankle Instability |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/17 18:17:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of Peroneal Muscle Function and Compensatory Movements in Individuals with Chronic Ankle Instability
Acronym
A Study on Peroneal Muscle Function in Individuals with Chronic Ankle Instability
Scientific Title
Functional Deficits of the Peroneus Longus and Brevis Muscles and Compensatory Strategies in Individuals with Chronic Ankle Instability
Scientific Title:Acronym
Peroneal Muscle Function in Chronic Ankle Instability
Region
| Japan |
Condition
Condition
Lateral Ankle Sprain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the morphological differences in the peroneal muscle group (peroneus longus and peroneus brevis) in subjects including those with chronic ankle instability (CAI), and to evaluate muscle activity during maximal voluntary contraction and torque-maintenance tasks under controlled conditions using a dynamometer.
Basic objectives2
Others
Basic objectives -Others
Morphological and neuromuscular characteristics of lower leg muscles, including muscle thickness, cross-sectional area, shear wave elastography (SWE), echo intensity, and electromyographic (EMG) activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity of the tibialis anterior, gastrocnemius, soleus, peroneus brevis, and peroneus longus.
Key secondary outcomes
The primary outcome measures were muscle thickness, cross-sectional area, muscle stiffness assessed by shear wave elastography (SWE), and muscle echo intensity of the tibialis anterior, gastrocnemius, soleus, peroneus longus, peroneus brevis, and tibialis posterior muscles.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Muscle morphology of the lower leg muscles is assessed using ultrasound imaging. Surface electromyography is used to record muscle activity during strength measurements.
Interventions/Control_2
Isometric ankle eversion tasks, including maximal voluntary contraction and torque maintenance tasks, are performed using a dynamometer to assess torque and muscle activity of the lower leg muscles.
Interventions/Control_3
Isometric ankle eversion torque maintenance tasks are performed under different ankle joint angle conditions (neutral and plantar flexion) using a dynamometer. After maximal voluntary contraction assessment, participants maintain target torque levels, and torque and muscle activity of the lower leg muscles are measured.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CAI Group (Chronic Ankle Instability)
1. A history of at least 1 ankle sprain.
2. Presence of "giving way", recurrent ankle sprains, or a subjective sense of instability, or meeting the cutoff scores of recommended questionnaires:
CAIT <= 24
AII: >= 5 "yes" responses including a history of ankle sprain
IdFAI >= 11
Coper Group
1. A history of at least 1 ankle sprain.
2. No recurrent ankle sprain for at least 1 year since the initial sprain.
3. CAIT >= 28 and/or IdFAI <= 10.
4. No subjective sense of ankle instability.
Control Group
1. No history of ankle sprain.
2. CAIT >= 28 and/or IdFAI <= 10.
Key exclusion criteria
1.Individuals with a history of fracture or surgery involving the foot or ankle.
2.Individuals presenting with lower limb injury, pain, or neurological disorders at the time of consent.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
makoto-komiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
Homepage URL
makoto-komiya@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Other
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
Ethics committee of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
Tel
0252574455
rinri@nuhw.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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070879
