NCT07594210

Brief Summary

This study aims to investigate the relationship between pelvic alignment and ankle stability in male athletes with and without a history of ankle sprain. Chronic ankle instability is a common condition that may affect not only the ankle joint but also the alignment and function of other body segments, including the pelvis. Understanding this relationship may help improve injury prevention and rehabilitation strategies. Participants will undergo clinical assessments, functional tests, and radiographic evaluation of pelvic parameters to compare findings between injured and non-injured groups. The objective of this study is to determine whether differences in pelvic sagittal parameters are associated with ankle instability in male athletes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 4, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 7, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 4, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

chronic ankle instabilityankle spraindynamic balancepelvic alignmentathletes

Outcome Measures

Primary Outcomes (6)

  • Ankle instability

    Ankle instability assessed using the Anterior Drawer Test

    Baseline assessment

  • Chronic ankle instability

    Chronic ankle instability severity assessed using the Cumberland Ankle Instability Tool (CAIT)

    Baseline assessment

  • Dynamic balance

    Dynamic balance performance assessed using the Y Balance Test

    Baseline assessment

  • Pelvic incidence

    Pelvic incidence measured using standing lateral pelvic radiographs

    Baseline assessment

  • Pelvic tilt

    Pelvic tilt measured using standing lateral pelvic radiographs

    Baseline assessment

  • Sacral slope

    Sacral slope measured using standing lateral pelvic radiographs

    Baseline assessment

Study Arms (2)

Group A: Male athletes with a history of ankle sprain and chronic ankle instability.

Group A Male Athletes With Chronic Ankle Instability Male competitive football players aged 18 to 35 years with a history of unilateral lateral ankle sprain and symptoms consistent with chronic ankle instability. Participants in this group will report recurrent episodes of ankle "giving way," perceived ankle weakness and/or reduced ankle function, and a Cumberland Ankle Instability Tool (CAIT) score of less than 24. The most recent ankle sprain must have occurred more than 3 months before enrollment.

Group B: Male athletes without a history of ankle sprain or chronic ankle instability.

Group B Healthy Male Athletes Male competitive football players aged 18 to 35 years with no previous history of lateral ankle sprain, chronic ankle instability, or lower limb musculoskeletal injury within the previous 12 months. Participants in this group will be matched to the chronic ankle instability group according to age, playing level, and training exposure.

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale athletes only
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include male competitive football players aged 18 to 35 years. Cases will be defined as players with chronic ankle instability following a history of lateral ankle sprain, while controls will be healthy players without a history of ankle sprain or chronic ankle instability. Participants will be recruited from sports clubs and physiotherapy outpatient departments.

You may qualify if:

  • Male football players aged between 18 and 35 years (Herzog et al., 2019; Jiang et al., 2022).
  • A documented history of lateral ankle sprain (LAS) for at least 12 months before the study, with the initial injury resulting in a minimum of one day of weight-bearing restriction.
  • Self-reported episodes of ankle "giving way" occurring at least twice within the 6-12 months preceding enrollment.
  • The most recent injury must have occurred more than 3 months before study enrollment.
  • A perceived sense of the injured ankle being chronically weaker and/or less functional than the contralateral side before the first LAS episode.
  • A Cumberland Ankle Instability Tool (CAIT) score of less than 24 indicates chronic ankle instability.
  • For group B: participants with no previous history of ankle sprain.

You may not qualify if:

  • Bilateral LAS (Tahoon et al., 2022).
  • Previous injury, fracture, or surgical intervention involving the spine, pelvis, or lower extremity.
  • History of low back pain requiring medical or surgical intervention.
  • Engagement in supervised or unsupervised ankle rehabilitation within one month before the study.
  • Any LAS occurring within three months before participation.
  • Leg length discrepancy exceeding 0.5 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Shakeri M, Mahdavi SM, Rikhtehgar M, Soleimani M, Ghandhari H, Jafari B, Daneshmand S. EOS(R) is reliable to evaluate spinopelvic parameters: a validation study. BMC Med Imaging. 2024 Feb 6;24(1):35. doi: 10.1186/s12880-023-01178-0.

  • Pierobon A, Raguzzi I, Solino S, Salzberg S, Vuoto T, Gilgado D, Perez Calvo E. Minimal detectable change and reliability of the star excursion balance test in patients with lateral ankle sprain. Physiother Res Int. 2020 Oct;25(4):e1850. doi: 10.1002/pri.1850. Epub 2020 May 26.

  • Plisky PJ, Rauh MJ, Kaminski TW, Underwood FB. Star Excursion Balance Test as a predictor of lower extremity injury in high school basketball players. J Orthop Sports Phys Ther. 2006 Dec;36(12):911-9. doi: 10.2519/jospt.2006.2244.

  • Powden CJ, Dodds TK, Gabriel EH. THE RELIABILITY OF THE STAR EXCURSION BALANCE TEST AND LOWER QUARTER Y-BALANCE TEST IN HEALTHY ADULTS: A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2019 Sep;14(5):683-694.

  • Fusco A, Giancotti GF, Fuchs PX, Wagner H, da Silva RA, Cortis C. Y balance test: Are we doing it right? J Sci Med Sport. 2020 Feb;23(2):194-199. doi: 10.1016/j.jsams.2019.09.016. Epub 2019 Sep 26.

  • Shdefat SA, Arshad Z, Khan R, Haq II, Bhatia M. Patient reported outcome measures in the foot and ankle literature: A systematic review. Foot (Edinb). 2025 Dec;65:102209. doi: 10.1016/j.foot.2025.102209. Epub 2025 Sep 29.

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • maha mostafa alibeiny, phd

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

ahmed korany Elsawy, Bsc

CONTACT

abdallah mohamed kamel, phd

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer at faculty of physical therapy

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 18, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

June 7, 2026

Study Completion (Estimated)

July 7, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share