Chronic Ankle Instability, CAINCT07051018
Radiological and Clinical Measures as Predictors of Dynamic Postural Control Deficits in Chronic Ankle Instability
An observational study of Chronic Ankle Instability, CAI, run by Cairo University.
Trial summary
The purpose of this study is to investigate the association between dynamic postural control and clinical measures of (ankle and hip strength, ankle DFROM and position sense) and radiological measures in patients with unilateral CAI. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Chronic Ankle Instability, CAI
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 20 Sep 2025
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: 50 participants, with age between 18- 30 years, diagnosed with unilateral CAI will be recruited through direct referrals based on their availability to participate, thus, a sample of convenience will be used.
Who may be able to join
- Participants will be screened for eligibility and only those who meet the inclusion criteria according to Delahunt et al. (2010) and Gribble et al. (2013) will be enrolled in our study, i.e., they will participate if they have:
- At least one significant unilateral lateral ankle sprain in which the subject was unable to walk independently without the aid of crutches (the first sprain occurred more than 12 months ago).
- Repeated bouts of lateral ankle injury (last injury had to be more than three months prior to inclusion in the study).
- Feeling of ankle instability "giving way", at least 2 episodes in the last 6 months (Terada et al., 2014).
- Pain during intense loading.
- The Cumberland Ankle Instability Tool (CAIT) ≤ 24.
- Age range of 18-30 years (Delahunt et al., 2010).
Who cannot join
- *Patients will be excluded if they didn't meet the inclusion criteria mentioned above, such as:
- A previous trauma or surgery to the trunk or lower extremities other than an ankle sprain.
- Neurological or vestibular impairments with remaining deficits.
- No participant with CAI had acutely sprained his or her ankle in the 3 months prior to the testing.
- Participants will be excluded if they have participated in any rehabilitation in the past 6 months.
- Concussion or head injury or lower back pain in the past 6 months.
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
The purpose of this study is to investigate the association between dynamic postural control and clinical measures of (ankle and hip strength, ankle DFROM and position sense) and radiological measures in patients with unilateral CAI.
Read the detailed description
Ankle sprains are among the most frequent injuries seen in emergency departments and in sports injury clinics. Among all ankle injuries, ankle sprains are the most common and account for approximately 80% of which 77% are lateral sprains. Ankle sprain incidence ranges from 5.3- 7.0 sprained ankles per one thousand persons per year in Europe and is estimated to be 23,000 ankle sprains occur per day in the United States. Up to 74% of individuals who sprained their ankle experience ongoing problems that prevent them from participating in sports and other physical activities. Lateral ankle sprain (LAS) typically occurs when the rear foot is supinated, and the leg is externally rotated. Inversion injuries affect the lateral ankle ligaments and subtalar ligaments concomitantly; around 73% of lateral ankle sprains are due to rupture or tear of the Anterior Talo-Fibular Ligament (ATFL), followed by Calcaneo Fibular Ligament (CFL) and cervical ligament of the subtalar joint with the interosseous talocalcaneal ligament respectively.
HYPOTHESES:
It will be hypothesized that:
- There will be no relation between the radiological measures of the ankle joint and dynamic postural control in patients with unilateral CAI.
- There will be no relation between hip muscles strength and dynamic postural control in patients with unilateral CAI.
- There will be no relation between ankle performance (muscle strength, DFROM and position sense) and dynamic postural control in patients with unilateral CAI.
- There will be a non-significant difference in the dynamic postural control between affected and normal lower limb.
- There will be a non-significant difference in the radiological measures between affected and normal lower limb.
- There will be a non-significant difference in the ankle performance between affected and normal lower limb.
- There will be a non-significant difference in the muscle strength around the hip joint between the affected and normal lower limb.
- Conditions
- Chronic Ankle Instability, CAI
- Keywords
- postural control, chronic ankle instability, talar tilt, tibiotalar contact ratio
What is being measured
The primary outcome is the main question the study is designed to answer.
Y- balance test
It is a dynamic balance test that assesses an individual's ability to maintain balance while reaching in three directions (anterior, posteromedial, and posterolateral) with one leg while standing on the other.
Measured: baseline
Secondary outcomes (1)
Radiographic measurements validated for non weight bearing radiographs (Talocrural Angle and Talar Tilt)
Tibiotalar contact ratio: this measurement represents congruency of the ankle joint on the lateral view . The measurements include the radius of the talus in mm, the height of the talus (h) in mm, and the tibiotalar sector (α) in degrees.
Talar Tilt: It is the angle between the longitudinal axis of the tibia and joint orientation line of the tibiotalar joint. It is categorized as varus (< 87°), normal (87-91°) or valgus (> 91°) position of the ankle.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Seif El-Eslam Youssif El-Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051018
- Sponsor's protocol ID
- P.T.REC/012/005628
- Status last verified
- Jul 2025
- First submitted
- 6 Apr 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Clinical Measures as Predictors of Dynamic Postural Control Deficits in Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT07051018
- Acronym / sponsor ID
- P.T.REC/012/005628
- Conditions
- Chronic Ankle Instability, CAI
- Keywords
- postural control, chronic ankle instability, talar tilt, tibiotalar contact ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 3 Jul 2025 (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.
The purpose of this study is to investigate the association between dynamic postural control and clinical measures of (ankle and hip strength, ankle DFROM and position sense) and radiological measures in patients with unilateral CAI.
Detailed description
Ankle sprains are among the most frequent injuries seen in emergency departments and in sports injury clinics. Among all ankle injuries, ankle sprains are the most common and account for approximately 80% of which 77% are lateral sprains. Ankle sprain incidence ranges from 5.3- 7.0 sprained ankles per one thousand persons per year in Europe and is estimated to be 23,000 ankle sprains occur per day in the United States. Up to 74% of individuals who sprained their ankle experience ongoing problems that prevent them from participating in sports and other physical activities. Lateral ankle sprain (LAS) typically occurs when the rear foot is supinated, and the leg is externally rotated. Inversion injuries affect the lateral ankle ligaments and subtalar ligaments concomitantly; around 73% of lateral ankle sprains are due to rupture or tear of the Anterior Talo-Fibular Ligament (ATFL), followed by Calcaneo Fibular Ligament (CFL) and cervical ligament of the subtalar joint with the interosseous talocalcaneal ligament respectively.
HYPOTHESES:
It will be hypothesized that:
- There will be no relation between the radiological measures of the ankle joint and dynamic postural control in patients with unilateral CAI.
- There will be no relation between hip muscles strength and dynamic postural control in patients with unilateral CAI.
- There will be no relation between ankle performance (muscle strength, DFROM and position sense) and dynamic postural control in patients with unilateral CAI.
- There will be a non-significant difference in the dynamic postural control between affected and normal lower limb.
- There will be a non-significant difference in the radiological measures between affected and normal lower limb.
- There will be a non-significant difference in the ankle performance between affected and normal lower limb.
- There will be a non-significant difference in the muscle strength around the hip joint between the affected and normal lower limb.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 50 participants, with age between 18- 30 years, diagnosed with unilateral CAI will be recruited through direct referrals based on their availability to participate, thus, a sample of convenience will be used.
Key inclusion criteria (7 listed)
- Participants will be screened for eligibility and only those who meet the inclusion criteria according to Delahunt et al. (2010) and Gribble et al. (2013) will be enrolled in our study, i.e., they will participate if they have:
Key exclusion criteria (6 listed)
- *Patients will be excluded if they didn't meet the inclusion criteria mentioned above, such as:
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
Y- balance test
Time frame: baseline
It is a dynamic balance test that assesses an individual's ability to maintain balance while reaching in three directions (anterior, posteromedial, and posterolateral) with one leg while standing on the other.
1 secondary outcome
Radiographic measurements validated for non weight bearing radiographs (Talocrural Angle and Talar Tilt)
Time frame: baseline
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 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, CAI, run by Cairo University.
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 3 Jul 2025. 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 Rana Seif Youssif, Lecturer Assistant (002 01014596607, rana_seif_pt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Y- balance test (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.