Bipedal vs. Unipedal Exercises in Chronic Ankle Instability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Early Bipedal Exercise
Other interventionProprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the first four weeks.
Late Bipedal Exercise
Other interventionProprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the last four weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Early Bipedal ExerciseActive comparator 1 intervention
Group B: Late Bipedal ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale
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.
Time frame
change from baseline at 6 months2
Single Leg Hop Test
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.
Time frame
3 times for 24 weeks3
Tampa Kinesiophoby Scoring
It is a 17-item scale developed to assess the fear of movement/re-injury.
Time frame
3 times for 24 weeksSecondary outcomes
1
Cumberland Ankle Instability Tool
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.
Time frame
3 times for 24 weeks2
Joint Range of Motion Evaluation
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.
Time frame
3 times for 24 weeks3
Foot and Ankle Ability Measure
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.
Time frame
3 times for 24 weeks4
Star Excursion Test
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.
Time frame
3 times for 24 weeksSponsors and contacts
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Istanbul University - Cerrahpasa
Lead sponsor
Bezmialem Vakif University
Collaborator
Acıbadem Atunizade Hospital
Collaborator
Source ClinicalTrials.gov