Bipedal vs. Unipedal Exercises in Chronic Ankle Instability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Bipedal Exercise, Late Bipedal Exercise.
- Who it may be relevant to
- Registry conditions: Instability; Ankle (Ligaments) (Old Injury). Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
When to Start Bipedal Exercises in Chronic Ankle Instability?
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Visual Analog Scale [Time frame: change from baseline at 6 months]
- Single Leg Hop Test [Time frame: 3 times for 24 weeks]
- Tampa Kinesiophoby Scoring [Time frame: 3 times for 24 weeks]
Secondary outcome measures (6)
- Cumberland Ankle Instability Tool [Time frame: 3 times for 24 weeks]
- Joint Range of Motion Evaluation [Time frame: 3 times for 24 weeks]
- Foot and Ankle Ability Measure [Time frame: 3 times for 24 weeks]
- Star Excursion Test [Time frame: 3 times for 24 weeks]
- Single Leg Stance Test [Time frame: 3 times for 24 weeks]
- Global Rating of Change Scale-GRC [Time frame: 2 times for 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Acibadem Mehmet Ali Aydinlar University — Istanbul
Publications
- Xue X, Ma T, Li Q, Song Y, Hua Y. Chronic ankle instability is associated with proprioception deficits: A systematic review and meta-analysis. J Sport Health Sci. 2021 Mar;10(2):182-191. doi: 10.1016/j.jshs.2020.09.014. Epub 2020 Oct 2. PMID 33017672
- van den Bekerom MP, Kerkhoffs GM, McCollum GA, Calder JD, van Dijk CN. Management of acute lateral ankle ligament injury in the athlete. Knee Surg Sports Traumatol Arthrosc. 2013 Jun;21(6):1390-5. doi: 10.1007/s00167-012-2252-7. Epub 2012 Oct 30. PMID 23108678
- Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375. PMID 12937557
- Malliaropoulos N, Bikos G, Meke M, Vasileios K, Valle X, Lohrer H, Maffulli N, Padhiar N. Higher frequency of hamstring injuries in elite track and field athletes who had a previous injury to the ankle - a 17 years observational cohort study. J Foot Ankle Res. 2018 Feb 26;11:7. doi: 10.1186/s13047-018-0247-4. eCollection 2018. PMID 29492109
- Diamond JE. Rehabilitation of ankle sprains. Clin Sports Med. 1989 Oct;8(4):877-91. PMID 2688911
- Dhillon MS, Patel S, Baburaj V. Ankle Sprain and Chronic Lateral Ankle Instability: Optimizing Conservative Treatment. Foot Ankle Clin. 2023 Jun;28(2):297-307. doi: 10.1016/j.fcl.2022.12.006. Epub 2023 Feb 26. PMID 37137624
- Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1. PMID 24377963
- Roy A, Gupta JK, Lahiri SC. Studies on anti-inflammatory, analgesic and antipyretic activities of some indan acids. Indian J Physiol Pharmacol. 1980 Oct-Dec;24(4):310-6. PMID 6971256
Identifiers
NCT: NCT06244511 · AESKA34893209