- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06801483
Ankle Strengthening in Athletes With Chronic Ankle Instability
March 19, 2026 updated by: China Medical University Hospital
Evaluation of the Effectiveness of Multiaxial Ankle Strengthening Training in Athletes With Chronic Ankle Instability
Chronic ankle instability (CAI) is a common complication following an ankle sprain, affecting joint stability and leading to decreased muscle strength and poor neuromuscular control.
These symptoms can significantly impact athletes' sports performance.
Rehabilitation training for CAI majorly involves strengthening or balance training.
Few studies have discussed treatment plans that combine the above two training, and the effectiveness of combined training is similar to that of single training content.
Due to the lack of machines to train ankle strength, thera-bands were often used for ankle strengthening.
However, the resistance thera-bands provide is limited and may need more for athletes requiring high-intensity training.
In recent years, a local company has developed a multiaxial ankle training system for machine-based ankle strengthening.
This machine allows for training the ankle joint in various directions while sitting and can provide greater training resistance.
As this machine has recently been developed and there is seldom evidence for its use in training, this project aims to discuss the effectiveness of using the ankle training machine in athletes with chronic ankle instability.
This study will compare the differences in muscle strength, morphology, muscle material properties, balance ability, and functional performance of athletes after a six-week combined training program with thera-band or the multiaxial ankle training system for providing resistance.
Thereby establishing a training plan for athletes suffering from chronic ankle instability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan
- China Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Unilateral CAI: Cumberland Ankle Instability Tool (CAIT) score ≤ 24
- Age between 18 and 28 years
- Engages in sports training at least 3 days a week, for more than 1 hour each session
- Able to perform training and assessment movements
Exclusion Criteria:
- Bilateral CAI
- Less than 6 months since the first ankle sprain
- Acute ankle sprain within the last 6 weeks
- Foot or ankle surgery within the last 3 months
- Neuromuscular diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: multiaxial ankle training system
These subjects will train their ankle strength by the multiaxial ankle training system
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All subjects will recieve an ankle muscle strenghening training program twice a week for six weeks.
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Active Comparator: thera-band
These subjects will train their ankle strength by thera-band
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All subjects will recieve an ankle muscle strenghening training program twice a week for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Morphology
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
Using ultrasound to measure the muscle morphology of the peronous longus, gastrocnemius, tibialis anterior.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
|
Y-Balance Test
Time Frame: At enrollment (1st week), midterm of training (3rd. week) and the end of training at 6 weeks
|
This test is divided into three directions: anterior, posteromedial, and posterolateral.
Each direction has a commercial measuring tape attached at 135 degrees, 90 degrees, and 135 degrees, respectively.
The subject stands in the middle of the three measuring tapes, with the test foot's toe placed at the intersection point.
The subject then stands on one leg with the test foot, extends the non-weight-bearing foot to touch the measuring tape in the target direction without touching the ground, and returns to the starting position while maintaining balance.
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At enrollment (1st week), midterm of training (3rd. week) and the end of training at 6 weeks
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Countermovement Jump
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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Before the test, wireless EMG sensors are attached to the tibialis anterior, The test is performed on a force plate.
The subject stands on the force plate, bends both knees to 90 degrees, and jumps as high as possible.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
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Triple Hop Test
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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The subject stands with both feet at the starting point in front of the force plate, then stands on one foot and performs three consecutive forward hops, with the first hop landing on the force plate.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle muscle strength
Time Frame: At enrollment (1st. week) and the end of intervention at 6 weeks
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Measuring muscle strength of dorsiflexion, plantarflexion, inversion and eversion by hand-hold dynamometer.
|
At enrollment (1st. week) and the end of intervention at 6 weeks
|
|
Muscle tension
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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The maximum values for muscle tension of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
|
At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
|
Muscle stiffness
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
The maximum values for muscle stiffness of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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Muscle elasticity
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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The maximum values for muscle elasticity of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
|
At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
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Muscle stress relaxation time
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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The maximum values for muscle stress relaxation time of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
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Muscle creep
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
The maximum values for muscle creep of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
|
Eyes Open/Eyes Closed Single-Leg Stance Test
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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This test includes static single-leg stance with eyes open/closed on stable/unstable surfaces, using a force plate to record the center of pressure changes during the test.
The starting posture is single-leg stance with hands on hips and the non-test foot lightly touching the inner ankle of the weight-bearing foot.
The subject maintains stable standing for 30 seconds.
If instability occurs, hands and feet can leave the body to maintain balance, but the test foot must not move.
If the other foot touches the ground, the test is considered a failure.
For the unstable surface test, a soft pad is placed on the force plate, and the subject stands on the pad.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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Muscle activation during countermovement Jump
Time Frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
|
The wireless EMG sensors are attached to the tibialis anterior, peroneus longus, and lateral gastrocnemius muscles to capture muscle activation during the activity.
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At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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Foot and Ankle Ability Measure (FAAM)
Time Frame: At enrollment (1st. week) and the end of training at 6 weeks
|
The Foot and Ankle Ability Measure (FAAM) is a self-reported functional assessment for the ankle joint, divided into two domains: Activities of Daily Living (FAAM-ADL) and Sports (FAAM-Sports), with 21 and 8 items, respectively.
Subjects rate the difficulty of performing each activity based on their perception, with 4 points for no difficulty and 0 points for unable to perform.
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At enrollment (1st. week) and the end of training at 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chia-Ming Chang, Ph.D., China Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2024
Primary Completion (Actual)
December 20, 2024
Study Completion (Actual)
January 31, 2026
Study Registration Dates
First Submitted
January 21, 2025
First Submitted That Met QC Criteria
January 24, 2025
First Posted (Actual)
January 30, 2025
Study Record Updates
Last Update Posted (Actual)
March 20, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH112-REC1-116(AR1)
- NSTC 113-2410-H-039-015 - (Other Grant/Funding Number: National Science and Technology Council, Taiwan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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