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Completed

NCT Number: NCT05602233

The Effect of Balance Training Following STARS on Postural Control

Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited.

The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of Sensory-Targeted Ankle Rehabilitation Strategies in the treatment of CAI.

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Key information

Conditions

Kinesiophobia Ankle Injuries Ankle Instability Ankle Sprains Anxiety Disorders Functional Performance Leg Injuries Mental Disorders Phobic Disorders Sensory Deficit Wounds and Injuries

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahcesehir University

Beşiktaş, Istanbul, 34353, Turkey (Türkiye)

About this study

Lateral ankle sprains are among the most common injuries in athletes and physically active individuals, accounting for 80% of ankle injuries. After the ankle is sprained for the first time, it becomes more prone to re-injury. Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. Long-term ongoing CAI symptoms; It includes pain, swelling, give away that reduces the person's quality of life.

Symptoms of CAI include both motor and sensory aspects of the sensorimotor system. Despite sensory and motor deficits in sensorimotor control, researches on CAI rehabilitation have focused on either motor or sensory components. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited.

Sensory-Targeted Ankle Rehabilitation Strategies (STARS) and balance training have proven to be effective in relieving CAI-associated deficits. Although the effects of isolated STARS were positive, in a recent study, there was no statistically significant difference between the groups when the balance training given with STARS was compared with the balance training alone. However, the reason for the lack of difference between the groups may be the simultaneous application of both treatment protocols. In addition, the effects of the isolated use of the STARS combination in the treatment of CAI are still unclear and to our knowledge, there are no studies in this area.

The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of STARS in the treatment of CAI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of first ankle sprain more than 1 year ago
  • Having at least 2 "give away" episodes in the last 6 months
  • Identification of Functional Ankle Instability's score above 11
  • 18-25 age range
  • Foot and Ankle Ability Measure (FAAM), the score of which is less than %90
  • Foot and Ankle Ability Measure Sports scale (FAAM-S), the score of which is less than %80

Exclusion criteria

  • History of lower extremity surgery
  • History of disease that may affect sensorimotor function in the lower extremity
  • Musculoskeletal disorders that may affect balance

Treatment and study plan

Exercise

Other

The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.

STARS (Sensory-Targeted Ankle Rehabilitation Strategies)

Other

STARS includes; joint mobilization, plantar massage and triceps surae stretching. The training will be given for 6 weeks, 3 times a week for 5 minutes.

Primary outcomes

  1. Postural control evaluation change

    Time frame: Change from Baseline postural control at 6 weeks

    Star excursion balance test (SEBT): The star excursion balance test is frequently used to evaluate the dynamic balance and postural control of the lower extremities. SEBT, is a test that measures the maximum reach of the individual by maintaining balance and performing a single-leg squat in lines drawn at 45 degrees intervals in eight different directions. The participant stands in the middle of the star shape with bare feet. For the starting position, the ankle should be stationary, the hands on the hips, and the participant should maintain the starting position throughout the test. The participant is asked to reach anteriorly, posteromedially and posterolaterally with the unstable ankle, make a light touch to the line, and rotate the outstretched leg back to the center while maintaining a one-leg stance with the other leg.The participant will be allowed to make 4 trials in each direction

Secondary outcomes

  1. Ankle dorsiflexion measurement change

    Time frame: Change from baseline ankle dorsiflexion measurement at 6 weeks

    Weight-bearing lunge test (WBLT) is frequently used in individuals with ankle instability in order to determine dorsiflexion normal joint movement. During WBLT the participant puts his hands on the wall and takes one leg forward and the other leg helps balance behind. The maximum distance that the knee touches the wall is recorded without allowing the heel of the front foot to lose contact with the ground.

  2. Function change

    Time frame: Change from baseline ankle function measurement at 6 weeks

    The Foot and Ankle Ability Measure is used to assess self-reported overall function levels in patients with leg, ankle, and foot musculoskeletal injuries and disorders. It consists of 2 subscales (Activities of Daily Living [ADL] and Sports [S]), both scored between 0% and 100%. The FAAM-ADL is a 21-item scale to assess function during activities of daily living. FAAM-Sport is an 8-item scale focusing on sports-related activities. Items in both tools are scored on a 5-point Likert scale ranging from 0 (no difficulty at all) to 4 (I can't do it). Scores are converted to percentages, and a higher percentage indicates a better level of function.

  3. Kinesiophobia change

    Time frame: Change from baseline kinesiophobia measurement at 6 weeks

    The Tampa kinesiophobia scale is often used in musculoskeletal injuries. TKS has a checklist of 17 questions. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Collaborators

  • Nevsehir Haci Bektas Veli University

Registry information

Official study title

The Effect of Balance Training Following STARS on Postural Control and Function in Athletes With Chronic Ankle Instability

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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