Chronic Ankle InstabilityNCT07594210
Pelvic Parameters in Males With and Without Ankle Instability
An observational study of Chronic Ankle Instability, run by Ahmed Korany Abdallah Ahmed.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2026to 7 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pelvic Parameters in Male Athletes With and Without Chronic Ankle Instability: A Cross Sectional Study
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.
Read more
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.
Read the detailed description
This cross-sectional case-control study aims to investigate the relationship between chronic ankle instability and pelvic sagittal alignment in male athletes. Chronic ankle instability may lead to alterations in lower limb biomechanics, postural control, and proximal body alignment, including pelvic positioning.
Participants will be divided into two groups: athletes with chronic ankle instability and healthy athletes without a history of ankle instability. All participants will undergo clinical evaluation, functional assessment, and radiographic measurement of pelvic sagittal parameters.
Clinical assessment will include evaluation of ankle instability severity, pain intensity, and dynamic balance performance using validated assessment tools. Pelvic alignment parameters will be assessed radiographically to identify potential biomechanical differences between groups.
The findings of this study may contribute to a better understanding of the relationship between chronic ankle instability and proximal biomechanical adaptations, which may improve rehabilitation and injury prevention strategies in athletes.
- Conditions
- Chronic Ankle Instability
- Keywords
- chronic ankle instability, ankle sprain, dynamic balance, pelvic alignment, athletes
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle instability
Ankle instability assessed using the Anterior Drawer Test
Measured: Baseline assessment
Chronic ankle instability
Chronic ankle instability severity assessed using the Cumberland Ankle Instability Tool (CAIT)
Measured: Baseline assessment
Dynamic balance
Dynamic balance performance assessed using the Y Balance Test
Measured: Baseline assessment
Pelvic incidence
Pelvic incidence measured using standing lateral pelvic radiographs
Measured: Baseline assessment
Pelvic tilt
Pelvic tilt measured using standing lateral pelvic radiographs
Measured: Baseline assessment
Sacral slope
Sacral slope measured using standing lateral pelvic radiographs
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start7 May 2026 (estimated)
- Primary completion7 Jun 2026 (estimated)
- Study completion7 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Korany Abdallah Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Korany Abdallah Ahmed, Cairo University
- Investigators
- maha mostafa alibeiny, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594210
- Sponsor's protocol ID
- Chronic ankle instability
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38321400Pierobon 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.
PubMed 32458531Plisky 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.
PubMed 17193868Powden 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.
PubMed 31598406Fusco 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.
PubMed 31601458Shdefat 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.
PubMed 41033023
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Parameters in Male Athletes With and Without Chronic Ankle Instability: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT07594210
- Acronym / sponsor ID
- Chronic ankle instability
- Conditions
- Chronic Ankle Instability
- Keywords
- chronic ankle instability, ankle sprain, dynamic balance, pelvic alignment, athletes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ahmed Korany Abdallah AhmedUniversity, hospital or other
- Study start
- 7 May 2026 (estimated)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 7 Jul 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This cross-sectional case-control study aims to investigate the relationship between chronic ankle instability and pelvic sagittal alignment in male athletes. Chronic ankle instability may lead to alterations in lower limb biomechanics, postural control, and proximal body alignment, including pelvic positioning.
Participants will be divided into two groups: athletes with chronic ankle instability and healthy athletes without a history of ankle instability. All participants will undergo clinical evaluation, functional assessment, and radiographic measurement of pelvic sagittal parameters.
Clinical assessment will include evaluation of ankle instability severity, pain intensity, and dynamic balance performance using validated assessment tools. Pelvic alignment parameters will be assessed radiographically to identify potential biomechanical differences between groups.
The findings of this study may contribute to a better understanding of the relationship between chronic ankle instability and proximal biomechanical adaptations, which may improve rehabilitation and injury prevention strategies in athletes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ankle instability
Time frame: Baseline assessment
Ankle instability assessed using the Anterior Drawer Test
Chronic ankle instability
Time frame: Baseline assessment
Chronic ankle instability severity assessed using the Cumberland Ankle Instability Tool (CAIT)
Dynamic balance
Time frame: Baseline assessment
Dynamic balance performance assessed using the Y Balance Test
Pelvic incidence
Time frame: Baseline assessment
Pelvic incidence measured using standing lateral pelvic radiographs
Pelvic tilt
Time frame: Baseline assessment
Pelvic tilt measured using standing lateral pelvic radiographs
Sacral slope
Time frame: Baseline assessment
Sacral slope measured using standing lateral pelvic radiographs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 38321400Shakeri 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.
- Results publication: PubMed 32458531Pierobon 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.
- Results publication: PubMed 17193868Plisky 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.
- Results publication: PubMed 31598406Powden 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.
- Results publication: PubMed 31601458Fusco 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.
- Results publication: PubMed 41033023Shdefat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
maha mostafa alibeiny, phd study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by Ahmed Korany Abdallah Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed korany Elsawy, Bsc (002-010-938-986-84, ahmedsawy442@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle instability (time frame: Baseline assessment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07594210, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.