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Chronic Ankle InstabilityNCT04360798

The Effectiveness of Unilateral and Bilateral Exercise Training in Patients With Lateral Ankle Instability

A study testing Unilateral Exercise Group and Bilateral Exercise Group in people with Chronic Ankle Instability, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

70% of the general population suffers ankle injuries at least once in their lifetime. The ankle lateral ligament injuries cause an average of 6.9 days of work loss, and it has been reported that the quality of life of these patients is affected by their long-term results. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Chronic Ankle Instability
What is being tested?
Unilateral Exercise Group and Bilateral Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2020to 1 Mar 2021
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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being a volunteer between the ages of 18-45
  • Mild (grade I), Moderate (grade II) or severe (grade III) lateral ankle sprain
  • Ability to understand and apply Turkish written and verbal instructions.

Who cannot join

  • Being an athlete
  • Previous surgical interventions for the musculoskeletal system structure on both lower extremities
  • History of fractures in both lower extremities
  • Acute injury of musculoskeletal structures of other lower limb joints in the past 3 months
  • Presence of chronic pain and edema in the foot or ankle unrelated to sprains
  • Presence of other lower extremity injuries
  • To have received a physiotherapy and rehabilitation program in the last 3 months

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • İstanbul Univercity-Cerrahpasa

    Istanbul, 16360

Other trials in Turkey (Türkiye)

About this study

Official title: The Comparison of the Effectiveness of Unilateral and Bilateral Exercise Training in Patients With Lateral Ankle Instability

70% of the general population suffers ankle injuries at least once in their lifetime. The ankle lateral ligament injuries cause an average of 6.9 days of work loss, and it has been reported that the quality of life of these patients is affected by their long-term results. Exercise training is important to prevent job loss, increase individuals' quality of life, or speed up their return to work. Functional or chronic insufficiency resulting from ankle ligament injury results in various abnormalities in the lower extremity. Motor coordination disorders due to instability, adhesions, peroneal muscle weakness, and loss of proprioception can be seen in the talus or subtalar joint. Instabilities are usually caused by loss of strength after an acute lateral ligament injury, hypomobility in the joint, inadequate improvement in proprioception, or inadequate healing of the ligament.

Almost 40% of patients with lateral ankle injury develop a condition known as chronic ankle instability. The cause of chronic ankle instability is classified as mechanical ankle instability (MAI) and functional ankle instability (FAI). While MAI is caused by ligament laxity, other factors such as proprioceptive problems, neuromuscular problems, postural control deficiencies, and muscle weakness are caused by FAI. For this reason, peroneal muscle strengthening, Achilles tendon stretching, balance training, and proprioceptive training are shown as the most important components of the treatment program in the rehabilitation of ankle instabilities. (5) It has been reported by many researchers that functional instability can be reduced and repetitive injuries can be prevented in patients given proprioceptive training and peroneal muscle strengthening on the balance board. In the results of another study evaluating bilaterally in the lower limb after balance training given to the intact side in individuals with chronic ankle instability, it was stated that the balance function of the unstable ankle was developed.

Although the treatment methods of ankle instability vary, there are very limited studies comparing treatment methods unilaterally and bilaterally in the ankle lateral instability in the literature. Our study will contribute to the literature to the next rehabilitation programs by comparing unilateral and bilateral exercise training prepared by rehabilitation protocols in many ways in two different groups.

Read the detailed description

Ankle ligament injuries are one of the most common musculoskeletal injuries among physically active people, accounting for ~ 14% of all sports-related orthopedic clinic visits. And it is stated that injuries that delay the return to sports the most. 4% of these injuries and the most common are the lateral ankle ligament injuries. 70% of the general population, not only specific to sports, suffers ankle injuries at least once in their lifetime. The ankle lateral ligament injuries cause an average of 6.9 days of work loss, and it has been reported that the quality of life of these patients is affected by their long-term results. When people who play sports are taken into consideration, an ankle sprain can affect the quality of life of the individual, as well as reduce performance and keep it away from education and competition.

Ankle sprains often occur during physical activities such as basketball and football, which require sudden stops, bounces, landings, and swings around a stable foot. Most lateral ankle sprains occur when combined with excessive inversion or adduction with additional plantar flexion.

Functional or chronic deficiencies develop in the lower limbs as a result of ankle ligament injury, resulting in various abnormalities. Motor coordination disorders due to instability, adhesions, peroneal muscle weakness, and loss of proprioception can be seen in the talus or subtalar joint. Instabilities are usually caused by loss of strength after an acute lateral ligament injury, hypomobility in the joint, inadequate improvement in proprioception, or inadequate healing of the ligament. Almost 40% of patients with lateral ankle injury develop a condition known as chronic ankle instability (CAI). CAI is characterized by the occurrence of recurrent cases of instability that cause constant ankle sprain and the giving-way sensation of the ankle after the first ankle sprain. The diagnostic criteria are detailed in the International Ankle Consortium, Cumberland Ankle Instability Tool (CAIT) is often used to evaluate functional ankle instability.

Among the most important factors causing instability in the ankle are proprioceptive disorders, pain, and muscle weakness. Therefore, rehabilitation programs generally focus on exercises that include muscle strengthening, balance training, neuromuscular training, and proprioceptive training protocols. In another combined supporting study, Huang et al. investigated the effects of combined balance exercises with plyometric exercise against plyometric exercise in individuals with functional ankle instability and showed that the combined program will reduce postural oscillation in static conditions, and improve stability and energy propagation models in dynamic postural control. One of the factors contributing to CAI is thought to be the loss of strength of the ankle circumference muscle groups in both concentric and eccentric directions. It is assumed that a decrease in the strength of the muscles of the more proximal joints, such as knee and hip, not just ankle oriented, may also be effective in the formation of CAI.

It has been shown in systematic review and meta-analysis that proprioception disorder contributes to chronic ankle imbalance. In another study in individuals with unilateral chronic ankle instability, both extremities were evaluated in terms of strength and proprioception, a decrease in the sensation of kinesthesia was observed, and loss of eversion force and proprioceptive disorders were reported on both sides.

Although ankle instability treatment approaches vary widely in all these studies, there is no detailed study comparing applications unilaterally and bilaterally in the literature. Our study will contribute to the literature to the next rehabilitation programs by comparing unilateral and bilateral exercise training prepared by rehabilitation protocols in many ways in two different groups

Being tested
Unilateral Exercise Group, Bilateral Exercise Group
Keywords
Lateral Ankle Instability, Unilateral Exercise, Billateral Exercise, Ankle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unilateral Exercise GroupOther

    Exercise programs will be practiced 60 days, 2 days a week for 4 weeks. The entire exercise protocol will be carried out under the supervision of a physiotherapist. During the treatment session, participants exercises will only be done for 60 minutes with the affected lower extremities.

  • Bilateral Exercise GroupOther

    Exercise programs will be practiced 60 days, 2 days a week for 4 weeks. The entire exercise protocol will be carried out under the supervision of a physiotherapist. During the treatment session, participants will complete their exercises with both lower extremities for 30 minutes.

Study groups in NCT04360798
Study groupRoleWhat they receive
Unilateral Exercise GroupExperimentalThe group to which exercise protocol consisting of strengthening, stretching, range of motion, static and dynamic postural control exercises will only be applied to the affected lower extremities of the participants.
Receives: Other: Unilateral Exercise Group
Bilateral Exercise GroupExperimentalThe group to which exercise protocol consisting of strengthening, stretching, range of motion, static and dynamic postural control exercises will be applied to the both lower extremities of the participants.
Receives: Other: Bilateral Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Foot and Ankle Ability Measure

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale. The Sports subscale assesses more difficult tasks that are essential to sport, it is a population-specific subscale designed for athlete

    Measured: 2 weeks

  2. Visual Analog Scale

    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.

    Measured: 2 weeks

  3. Single Heel Rise Test

    It is used to test the muscle strength of the ankle plantar flexors. The participants will be asked to repeat the movement until the point they cannot perform due to pain or fatigue, and their repetition numbers will be noted. In the test, the number of 25 repeats is considered normal.

    Measured: 2 weeks

  4. Single Leg Stance Test

    Single Leg Stance Test is used to measure static balance. The person is asked to stand on one leg for 60 seconds.

    The time it remains in balance is recorded. Contact of the leg in the air with any surface is considered unsuccessful. It is applied in two different ways: eyes open and eyes closed.

    Measured: 2 weeks

  5. Assesment of Lower Limb Muscle Strength

    Hand held dynamometer, which is a valid and reliable method, will be used to evaluate the muscle strength of the lower limbs. Plantar flexion, dorsiflexion inversion and eversion muscle strength, hip flexion, extension, abduction, adduction, internal rotation and external rotation muscle strength of the participants will be measured. The highest value obtained by performing 3 attempts in each measurement will be recorded.

    Measured: 2 weeks

  6. Balance Error Scoring System

    The Balance Error Scoring System is an objective measure of assessing static postural stability. In the evaluations, 2 different surfaces are used, one of which is hard and the other is soft ground. .Postural stability is evaluated for 20 seconds in 3 different positions as double foot, single foot and tandem posture on each floor. Scoring is done according to the number of errors made. The lowest score is 0 errors and the highest score is 6. Points from the subcategory are added to calculate the total score.

    Measured: 2 weeks

  7. Star Excursion Balance Test

    It is used to evaluate the dynamic balance and postural control of the participants. The test layout consists of 8 lines arranged at a 45 ° angle from a center point. Participants will be asked to reach as much as possible in 8 different directions with one leg while standing in balance with one leg. The distance reached is recorded.

    Measured: 2 weeks

  8. Joint Position Sensation Measurement

    The perception of the joint position is measured by active and passive repositioning.

    Passive repositioning: The person to be tested is asked to learn the position by positioning the joint at a certain angle. Then, when the joint is passively moved, it is asked to stop the movement when it reaches the previously learned position. The numerical difference between the angle the person finds and the angle previously taught is evaluated.

    Active repositioning: The person who was previously taught to find the position taught by the person is asked to move and the numerical difference is recorded.

    Measured: 2 weeks

  9. Vertical Jump Test

    The Vertical Jump (Sargent Jump) test is used to assess the person's vertical explosive force. In the test, the maximum height that the person can reach by lifting his arm while standing still is measured. Then the person is asked to jump as high as he can reach where he is. In the evaluation, the difference between the height that the individual can reach when standing and the height that he can reach by jumping is taken. This test is repeated three times, the best of all jumps are the performance of the person.

    Measured: 2 weeks

  10. Single Leg Jumping Distance Measurement

    Single Leg Jump test is a valid and reliable functional performance test where participants are asked to jump forward as much as possible (53). The distance between the jump is measured by reference to the toes.

    Measured: 2 weeks

  11. Side jump Test

    Participants are asked to jump 30 cm on one leg. It consists of jumping up to 30 cm again and returning to the starting point. Each participant is asked to repeat 10 times and do it as quickly as possible. Completion time is recorded.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start1 May 2020
  3. Primary completion1 Aug 2020
  4. Study completion1 Mar 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360798
Sponsor's protocol ID
Bpamukcu
Status last verified
Apr 2021
First submitted
22 Apr 2020
Last updated
27 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Unilateral Exercise Group and Bilateral Exercise Group in people with Chronic Ankle Instability, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

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 3 inclusion and 7 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 27 Apr 2021. 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 Turkey (Türkiye). 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?

Foot and Ankle Ability Measure (time frame: 2 weeks). The study lists 11 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 27 Apr 2021.

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