Bipedal vs. Unipedal Exercises in Chronic Ankle Instability

March 21, 2025 updated by: Aysenur Erekdag, Istanbul University - Cerrahpasa

When to Start Bipedal Exercises in Chronic Ankle Instability?

Ankle sprain is a commonly encountered condition in clinical practice, constituting approximately 15-30% of all musculoskeletal injuries. Long-term studies have demonstrated that up to 73% of patients experience at least one more ankle sprain following an acute ankle sprain. Inadequate treatment of acute ankle instability can lead to chronic ankle instability (CAI) in 30-70% of cases.

Treatment approaches for CAI are classified into conservative and surgical methods. Typically, conservative treatment is initially employed to address proprioceptive deficits and static impairments. Passive, unidirectional treatments such as injections, electrotherapy, and ice, which do not target muscle strength, kinetic chain, tendon capacity, and cortical control, are reported to be insufficient or ineffective in treating CAI, relying solely on symptomatic relief. Therefore, therapeutic exercises are fundamental in CAI treatment, leading to positive developments in parameters such as strength, dynamic balance, functional status, quality of life, and injury risk. Among the most commonly used exercise approaches are proprioceptive and resistive exercises.

Upon reviewing the literature, it is observed that bipedal exercises have been employed from the early stages of CAI. However, due to clinical symptoms such as pain, insecurity, and fear associated with loading the affected limb, patients tend to avoid putting weight on the affected limb, resulting in the frequent use of bipedal exercises in the early phases of rehabilitation.

The aim of this study is to comparatively examine the effectiveness of unipedal exercise interventions used in the early stages of rehabilitation for individuals with CAI in terms of pain, functional stability, fear avoidance, disease severity, functional performance, balance, and patient satisfaction, in comparison to bipedal exercise interventions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Voluntary participants who have been diagnosed with chronic ankle instability will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. The study groups will be as follows: a) early bipedal exercise group, b) late bipedal exercise group.

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Contact Backup

  • Name: Sezen Karabörklü Argut, PhD
  • Phone Number: 05301712421
  • Email: sezenpt@gmail.com

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Recruiting
        • Acibadem Mehmet Ali Aydinlar University
        • Contact:

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:

  • The documented unilateral ankle instability confirmed through clinical examinations (drawer test, talar tilt test) and MRI in cases requiring differential diagnosis.
  • A history of an initial ankle sprain occurring at least 6 months ago.
  • The presence of a recurrent sense of giving way that started at least 6 months ago and has been intermittently persistent.

Exclusion Criteria:

  • Presence of a history of previous surgery in the lower extremity.
  • Identification of organic and non-organic lesions such as cartilage injuries, periarticular tendon tears, and impingement syndromes.
  • The existence of a fracture accompanying instability in the foot-ankle.
  • Presence of congenital deformities in the foot-ankle.
  • Diagnosis of talus osteochondral lesion.
  • Diagnosis of ankle arthritis.
  • Presence of medial ligament lesion.
  • Existence of peripheral neuropathy.
  • Presence of additional rheumatological diseases.
  • Regular moderate-level exercise for at least 3 days a week in the last 6 months.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early Bipedal Exercise
Individuals with a diagnosis of chronic ankle instability who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week.
Other: Early Bipedal Exercise
Proprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the first four weeks.
Active Comparator: Late Bipedal Exercise
Individuals with a diagnosis of chronic ankle instability who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week.
Other: Late Bipedal Exercise
Proprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the last four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: change from baseline at 6 months
Patients will be asked to use a 100 mm scale to indicate the intensity of ankle pain by marking a point on the scale. As the marked point approaches 100, it will represent an increase in perceived pain intensity. The location marked on the scale closer to 100 will indicate a higher level of perceived pain.
change from baseline at 6 months
Single Leg Hop Test
Time Frame: 3 times for 24 weeks
It is an athletic performance test designed to assess the functional stability of patients. In this test, participants are instructed to perform lateral hops as far as possible, and the recorded distance of their jumps serves as a score, reflecting their functional stability.
3 times for 24 weeks
Tampa Kinesiophoby Scoring
Time Frame: 3 times for 24 weeks
It is a 17-item scale developed to assess the fear of movement/re-injury.
3 times for 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumberland Ankle Instability Tool
Time Frame: 3 times for 24 weeks
It is a 30-point, 9-item scale measuring the severity of functional ankle instability. Lower scores indicate functional ankle instability. The Minimal Clinically Important Difference for this valid and reliable scale is 3 points.
3 times for 24 weeks
Joint Range of Motion Evaluation
Time Frame: 3 times for 24 weeks
During the assessments, three repeat measurements will be made using an electronic goniometer. For goniometric measurement, the pivot point will be placed on the lateral malleolus. The fixed arm will be kept parallel to the lateral midline of the fibula. The moving arm, on the other hand, will follow the lateral midline of the 5th metatarsal bone.
3 times for 24 weeks
Foot and Ankle Ability Measure
Time Frame: 3 times for 24 weeks
This tool has been developed as a self-report instrument to comprehensively assess physical performance among individuals with various lower extremity musculoskeletal disorders, including leg, foot, and ankle conditions. It consists of 23 questions covering sub-parameters such as activity limitation, disability, and pain. Higher scores on the tool indicate greater impairment and lower function.
3 times for 24 weeks
Star Excursion Test
Time Frame: 3 times for 24 weeks
Physical performance that requires strength, flexibility, and proprioception is assessed through a dynamic test evaluating dynamic postural control and lower extremity injury risk associated with musculoskeletal injuries. The protocol of the test involves maintaining balance on the ipsilateral leg while reaching as far as possible with the contralateral leg.
3 times for 24 weeks
Single Leg Stance Test
Time Frame: 3 times for 24 weeks
Participants' standing balance will be assessed. Initially, one foot will be positioned on a firm and flat surface with the entire lower extremity in full extension, while the other lower extremity is positioned with the hip and knee flexed at 90 degrees. With their eyes closed, participants will start the timing when the foot not being tested loses contact with the ground, and the timing will stop when they place their foot back on the ground or when there is a significant increase in body sway.
3 times for 24 weeks
Global Rating of Change Scale-GRC
Time Frame: 2 times for 24 weeks

It will be used to evaluate patient satisfaction. It is designed to determine the amount of improvement or worsening of the patient over time.

In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) was preferred.
2 times for 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Collaborators

Bezmialem Vakif University
Acıbadem Atunizade Hospital

Investigators

  • Principal Investigator: Ayşenur Erekdağ, MSc, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 4, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AESKA34893209

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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