Bipedal vs. Unipedal Exercises in Chronic Ankle Instability

Not Applicable

Recruiting

• Conditions: Instability; Ankle (Ligaments) (Old Injury)

• Registration Number: NCT06244511
• Lead Sponsor: Istanbul University - Cerrahpasa

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Study Start: 2024-03-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-03-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Single Leg Hop Test	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.
Visual Analog Scale	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.
Tampa Kinesiophoby Scoring	3 times for 24 weeks	It is a 17-item scale developed to assess the fear of movement/re-injury.

Secondary Outcome Measures

Name	Time	Method
Cumberland Ankle Instability Tool	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.
Joint Range of Motion Evaluation	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.
Single Leg Stance Test	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.
Foot and Ankle Ability Measure	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.
Star Excursion Test	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.
Global Rating of Change Scale-GRC	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.

Trial Locations

Locations (1)

Acibadem Mehmet Ali Aydinlar University; 🇹🇷 Istanbul, Turkey