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

NCT04360798 | Completed

• 1 other identifier: Bpamukcu
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Ankle Instability

Keywords

Lateral Ankle Instability; Unilateral Exercise; Billateral Exercise; Ankle

Outcome Measures

Primary Outcomes (11)

• 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

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

Study Arms (2)

Unilateral Exercise Group

EXPERIMENTAL

The 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.

Other: Unilateral Exercise Group

Bilateral Exercise Group

EXPERIMENTAL

The 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.

Other: Bilateral Exercise Group

Interventions

Unilateral Exercise Group OTHER

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.

Unilateral Exercise Group

Bilateral Exercise Group OTHER

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.

Bilateral Exercise Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul Univercity-Cerrahpasa

Istanbul, 16360, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

TU (1)