Bipedal vs. Unipedal Exercises in Chronic Ankle Instability

NCT06244511 | Recruiting

• 1 other identifier: AESKA34893209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Instability; Ankle (Ligaments) (Old Injury)

Keywords

Proprioseptive exercise; Resistive exercise; Chronic ankle instability; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  change from baseline at 6 months

• 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.

  3 times for 24 weeks

• Tampa Kinesiophoby Scoring

  It is a 17-item scale developed to assess the fear of movement/re-injury.

  3 times for 24 weeks

Secondary Outcomes (6)

• Cumberland Ankle Instability Tool

  3 times for 24 weeks

• Joint Range of Motion Evaluation

  3 times for 24 weeks

• Foot and Ankle Ability Measure

  3 times for 24 weeks

• Star Excursion Test

  3 times for 24 weeks

• Single Leg Stance Test

  3 times for 24 weeks

Study Arms (2)

Early Bipedal Exercise

ACTIVE COMPARATOR

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

Late Bipedal Exercise

ACTIVE COMPARATOR

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

Interventions

Early Bipedal Exercise OTHER

Proprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the first four weeks.

Early Bipedal Exercise

Late Bipedal Exercise OTHER

Proprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the last four weeks.

Late Bipedal Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bezmialem Vakif University: collaborator
• Acıbadem Atunizade Hospital: collaborator

Study Sites (1)

Acibadem Mehmet Ali Aydinlar University

Istanbul, 34752, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.

  PMID: 12937557 BACKGROUND

• 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 BACKGROUND

• Diamond JE. Rehabilitation of ankle sprains. Clin Sports Med. 1989 Oct;8(4):877-91.

  PMID: 2688911 BACKGROUND

• 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 BACKGROUND

• 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: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.

  PMID: 24377963 BACKGROUND

• 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 BACKGROUND

• Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.

  PMID: 16971246 BACKGROUND

• Martin RL, Davenport TE, Fraser JJ, Sawdon-Bea J, Carcia CR, Carroll LA, Kivlan BR, Carreira D. Ankle Stability and Movement Coordination Impairments: Lateral Ankle Ligament Sprains Revision 2021. J Orthop Sports Phys Ther. 2021 Apr;51(4):CPG1-CPG80. doi: 10.2519/jospt.2021.0302.

  PMID: 33789434 BACKGROUND

Study Officials

• Ayşenur Erekdağ, MSc

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşenur Erekdağ, MSc

CONTACT

05548959013; aysenurerekdag@gmail.com

Sezen Karabörklü Argut, PhD

CONTACT

05301712421; sezenpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will not know which participant received which intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be an equal number of participants in the two groups randomized by the computer.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: March 4, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

TU (1)