Ireland
--:--IST
Recruiting Not applicable

Bipedal vs. Unipedal Exercises in Chronic Ankle Instability

NCT06244511 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-03-04
Last updated
2025-03-24

Condition(s) studied

Instability; Ankle (Ligaments) (Old Injury)

Investigational drug(s) / intervention(s)

Early Bipedal ExerciseLate Bipedal Exercise

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.
  • 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.
  • Tampa Kinesiophoby Scoring — 3 times for 24 weeks
    It is a 17-item scale developed to assess the fear of movement/re-injury.

Trial sites (1)

FacilityCityRegionStatus
Acibadem Mehmet Ali Aydinlar University Istanbul Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244511 on ClinicalTrials.gov ↗ ← All trials in Turkey