Chronic Ankle Instability, CAINCT06801483
Ankle Strengthening in Athletes With Chronic Ankle Instability
A study testing Strengthening in people with Chronic Ankle Instability, CAI and Athletes, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Chronic Ankle Instability, CAI, Athletes
- What is being tested?
- Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Ankle Instability, CAI, Athletes
- Being tested
- Strengthening
- Keywords
- progressive training, strengthening, balance training, chronic ankle instability, ankle training machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrengtheningOther
All subjects will recieve an ankle muscle strenghening training program twice a week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| multiaxial ankle training system | Experimental | These subjects will train their ankle strength by the multiaxial ankle training system Receives: Other: Strengthening |
| thera-band | Active comparator | These subjects will train their ankle strength by thera-band Receives: Other: Strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Morphology
Using ultrasound to measure the muscle morphology of the peronous longus, gastrocnemius, tibialis anterior.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Y-Balance Test
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.
Measured: At enrollment (1st week), midterm of training (3rd. week) and the end of training at 6 weeks
Countermovement Jump
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.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Triple Hop Test
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.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Secondary outcomes (9)
Ankle muscle strength
Measuring muscle strength of dorsiflexion, plantarflexion, inversion and eversion by hand-hold dynamometer.
Measured: At enrollment (1st. week) and the end of intervention at 6 weeks
Muscle tension
The maximum values for muscle tension of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle stiffness
The maximum values for muscle stiffness of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle elasticity
The maximum values for muscle elasticity of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle stress relaxation time
The maximum values for muscle stress relaxation time of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle creep
The maximum values for muscle creep of tibialis anterior, lateral gastrocnemius, and peroneus longus muscles are evaluated by the MyotonPRO.
Measured: 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
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.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle activation during countermovement Jump
The wireless EMG sensors are attached to the tibialis anterior, peroneus longus, and lateral gastrocnemius muscles to capture muscle activation during the activity.
Measured: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Foot and Ankle Ability Measure (FAAM)
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.
Measured: At enrollment (1st. week) and the end of training at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Aug 2024
- Primary completion20 Dec 2024
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chia-Ming Chang, Ph.D., Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801483
- Sponsor's protocol ID
- CMUH112-REC1-116(AR1)
- Other IDs
- NSTC 113-2410-H-039-015 -
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Multiaxial Ankle Strengthening Training in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06801483
- Acronym / sponsor ID
- CMUH112-REC1-116(AR1)
- Conditions
- Chronic Ankle Instability, CAI, Athletes
- Keywords
- progressive training, strengthening, balance training, chronic ankle instability, ankle training machine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiaxial ankle training system | Experimental | Other: StrengtheningThese subjects will train their ankle strength by the multiaxial ankle training system |
| thera-band | Active comparator | Other: StrengtheningThese subjects will train their ankle strength by thera-band |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrengtheningAll subjects will recieve an ankle muscle strenghening training program twice a week for six weeks. | Other | multiaxial ankle training system, thera-band |
Primary outcome
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.
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.
Countermovement Jump
Time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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.
Triple Hop Test
Time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
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.
9 secondary outcomes
Ankle muscle strength
Time frame: 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
Muscle stiffness
Time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle elasticity
Time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle stress relaxation time
Time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Muscle creep
Time frame: 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
Muscle activation during countermovement Jump
Time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks
Foot and Ankle Ability Measure (FAAM)
Time frame: At enrollment (1st. week) and the end of training at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ming Chang, Ph.D. principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening in people with Chronic Ankle Instability, CAI and Athletes, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Morphology (time frame: At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.