Bipedal vs. Unipedal Exercises in Chronic Ankle Instability

NCT ID: NCT06244511

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Instability; Ankle (Ligaments) (Old Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be an equal number of participants in the two groups randomized by the computer.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessor will not know which participant received which intervention.

Study Groups

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Early Bipedal Exercise

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.

Group Type ACTIVE_COMPARATOR

Early Bipedal Exercise

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Late Bipedal Exercise

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role collaborator

Acıbadem Atunizade Hospital

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Aysenur Erekdag

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşenur Erekdağ, MSc

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Acibadem Mehmet Ali Aydinlar University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşenur Erekdağ, MSc

Role: CONTACT

05548959013

Sezen Karabörklü Argut, PhD

Role: CONTACT

05301712421

Facility Contacts

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Tekin K Ulku, Assoc. Prof.

Role: primary

+902166494444

References

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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.

Reference Type BACKGROUND
PMID: 33017672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23108678 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12937557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29492109 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2688911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37137624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24377963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6971256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16971246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33789434 (View on PubMed)

Other Identifiers

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AESKA34893209

Identifier Type: -

Identifier Source: org_study_id

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