Functional Ankle InstabilityNCT06715033
Relationship Between Ankle Planterflexors Peak Torque and Balance in Patients With Functional Ankle Instability
An observational study of Functional Ankle Instability, run by Cairo University at 1 site in Egypt.
Trial summary
This study attempted to: 1. Investigate the difference in calf muscle strength (concentric and eccentric) between affected limb with instability and non-affected limb. 2. Assess the relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocity (60 and 120◦/s) in… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Functional Ankle Instability
- What is being tested?
- y balance and SLS
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2024to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: age sex
Who may be able to join
- Subjects' selection was based on the following criteria:
- Age ranged from 18 to 25 years
- The body mass index was 18.5 to 24.9 kg/m2
- History of at least one unilateral lateral ankle sprain that needed to be immobilized for three days or longer
- At least one recurring sprain in the three to six months before study participation.
- FAI if their total score is 11 or above by IdFAI.
Who cannot join
- Subjects were excluded if they had any of the following criteria:
- Previous Ankle surgery.
- Patients with bilateral ankle instability.
- Syndesmotic and medial ankle sprain .
- Severe ankle arthritis.
- Neurological disorders affect ankle function.
- No history of ankle fractures .
Trial locations and contacts
1 site in 1 country.
About this study
This study attempted to:
- Investigate the difference in calf muscle strength (concentric and eccentric) between affected limb with instability and non-affected limb.
- Assess the relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocity (60 and 120◦/s) in patients with functional ankle instability?
- Investigate the relationship between calf muscle strength (concentric and eccentric) deficit and functional performance in functional ankle instability.
Read the detailed description
Statement of the problem Was there a difference in calf muscle strength (concentric and eccentric) between the affected limb with instability and the non-affected limb? Was there a relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocities of 60 and 120°/s in patients with functional ankle instability? Was there a relationship between calf muscle strength (concentric and eccentric) deficits and functional performance in patients with functional ankle instability?
Purpose of The Study
This study attempted to:
- Investigate the difference in calf muscle strength (concentric and eccentric) between affected limb with instability and non-affected limb.
- Assess the relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocity (60 and 120◦/s) in patients with functional ankle instability?
- Investigate the relationship between calf muscle strength (concentric and eccentric) deficit and functional performance in functional ankle instability.
Significance of study Chronic ankle instability is recognized as one of the most common lower-extremity disorders encountered by orthopedic physical therapists The prevalence of CAI varies from 0.7% to 1.1% in young people, 20% in student-athletes, 23.4% in collegiate and high school athletes, and 29% in high school pupils Incidents of CAI are roughly 7/1000 person-years in the general population and up to 45/1000 person-years in those who engage in physical activity Chronic ankle instability may develop as a result of improper post-injury management and a lack of medical attention.
There is an urgent need for diagnostic and measurement methods to pinpoint and follow people who are at risk of CAI.
Lack of research on plantar flexors and additional studies evaluating isokinetic ankle torque values are necessary.
Different studies examined ankle muscles (evertors, invertors, dorsiflexors, and plantar flexors) eccentric contractions only, and no one study examined calf muscle concentric and eccentric contractions in CAI.
Several studies have provided evidence that concentric plantarflexor strength are impaired CAI.
Insufficient strength of plantarflexor may alter performance, hence this study will instruct strength of calf muscles to prevent ankle injury.
Effective evaluation is the first step toward effective treatment; earlier research limited the fundamental basis for rehabilitation after ankle injury by failing to identify variables linked to symptoms of ankle instability.
Functional tests are useful as a guide for rehabilitation outcomes because they can identify deficiencies in muscular strength and functional performance limits. So far, there is no gold standard for the assessment and treatment of chronic ankle instability.
Up to the authors' knowledge, there is limited evidence about calf muscle strength, which is neglected in rehabilitating chronic ankle instability. Therefore, this study will assess calf muscle strength in patients with functional ankle instability. This trial will guide physical therapists to address calf muscle strength in assessment and treatment procedures for managing FAI.
Hypotheses of the Study
- There was no statistical relationship between the severity of functional ankle instability and calf muscle strength (concentric and eccentric) in patients with ankle instability.
- There was no statistically significant difference in calf muscle strength (concentric and eccentric) at velocities of 60°/s and 120°/s between the affected limb with ankle instability and the non-affected limb.
- There was no statistical relationship between calf muscle strength (concentric and eccentric) and dynamic balance in patients with ankle instability.
- There was no statistical relationship between calf muscle strength (concentric and eccentric) and static balance in patients with ankle instability.
- Conditions
- Functional Ankle Instability
- Being tested
- y balance and SLS
- Keywords
- Calf Muscles, Isokinetic, Y balance, Side hop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
y balance and SLSDiagnostic test
Also called side hop
for assessment of static and dynamic balance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group A (Experimental): 34 affected ankles of both genders diagnosed with functional ankle instability (FAI) who met the inclusion criteria. Their ages ranged from 18 to 25 years, and the patients had a history of initial injury, ongoing bouts of instability, and ratings of patient-perceived function and disability. Receives: Diagnostic Test: y balance and SLS | |
| 2 | Group B (Control): This group consisted of 34 matched non-affected ankles in the study. Receives: Diagnostic Test: y balance and SLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic version of the Identification of Functional Ankle Instability questionnaire (IdFAI-AR)
asses of FAI
Measured: 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start24 May 2024
- Primary completion22 Jun 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Ankle InstabilityStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohammed Mahmoud Khafaga, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715033
- Sponsor's protocol ID
- P.TREC/012/005361
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abdelkader NA, Khafagaa MM, Aziz MZ. The gastrocnemius and soleus muscles deficits in functional ankle instability: an observational study. BMC Musculoskelet Disord. 2025 Nov 14;26(1):1046. doi: 10.1186/s12891-025-09286-4.
PubMed 41239273
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Ankle Planterflexors Peak Torque and Balance in Patients With Functional Ankle Instability
- ClinicalTrials.gov ID
- NCT06715033
- Acronym / sponsor ID
- P.TREC/012/005361
- Conditions
- Functional Ankle Instability
- Keywords
- Calf Muscles, Isokinetic, Y balance, Side hop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 4 Dec 2024 (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 attempted to:
- Investigate the difference in calf muscle strength (concentric and eccentric) between affected limb with instability and non-affected limb.
- Assess the relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocity (60 and 120◦/s) in patients with functional ankle instability?
- Investigate the relationship between calf muscle strength (concentric and eccentric) deficit and functional performance in functional ankle instability.
Detailed description
Statement of the problem Was there a difference in calf muscle strength (concentric and eccentric) between the affected limb with instability and the non-affected limb? Was there a relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocities of 60 and 120°/s in patients with functional ankle instability? Was there a relationship between calf muscle strength (concentric and eccentric) deficits and functional performance in patients with functional ankle instability?
Purpose of The Study
This study attempted to:
- Investigate the difference in calf muscle strength (concentric and eccentric) between affected limb with instability and non-affected limb.
- Assess the relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocity (60 and 120◦/s) in patients with functional ankle instability?
- Investigate the relationship between calf muscle strength (concentric and eccentric) deficit and functional performance in functional ankle instability.
Significance of study Chronic ankle instability is recognized as one of the most common lower-extremity disorders encountered by orthopedic physical therapists The prevalence of CAI varies from 0.7% to 1.1% in young people, 20% in student-athletes, 23.4% in collegiate and high school athletes, and 29% in high school pupils Incidents of CAI are roughly 7/1000 person-years in the general population and up to 45/1000 person-years in those who engage in physical activity Chronic ankle instability may develop as a result of improper post-injury management and a lack of medical attention.
There is an urgent need for diagnostic and measurement methods to pinpoint and follow people who are at risk of CAI.
Lack of research on plantar flexors and additional studies evaluating isokinetic ankle torque values are necessary.
Different studies examined ankle muscles (evertors, invertors, dorsiflexors, and plantar flexors) eccentric contractions only, and no one study examined calf muscle concentric and eccentric contractions in CAI.
Several studies have provided evidence that concentric plantarflexor strength are impaired CAI.
Insufficient strength of plantarflexor may alter performance, hence this study will instruct strength of calf muscles to prevent ankle injury.
Effective evaluation is the first step toward effective treatment; earlier research limited the fundamental basis for rehabilitation after ankle injury by failing to identify variables linked to symptoms of ankle instability.
Functional tests are useful as a guide for rehabilitation outcomes because they can identify deficiencies in muscular strength and functional performance limits. So far, there is no gold standard for the assessment and treatment of chronic ankle instability.
Up to the authors' knowledge, there is limited evidence about calf muscle strength, which is neglected in rehabilitating chronic ankle instability. Therefore, this study will assess calf muscle strength in patients with functional ankle instability. This trial will guide physical therapists to address calf muscle strength in assessment and treatment procedures for managing FAI.
Hypotheses of the Study
- There was no statistical relationship between the severity of functional ankle instability and calf muscle strength (concentric and eccentric) in patients with ankle instability.
- There was no statistically significant difference in calf muscle strength (concentric and eccentric) at velocities of 60°/s and 120°/s between the affected limb with ankle instability and the non-affected limb.
- There was no statistical relationship between calf muscle strength (concentric and eccentric) and dynamic balance in patients with ankle instability.
- There was no statistical relationship between calf muscle strength (concentric and eccentric) and static balance in patients with ankle instability.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: y balance and SLSGroup A (Experimental): 34 affected ankles of both genders diagnosed with functional ankle instability (FAI) who met the inclusion criteria. Their ages ranged from 18 to 25 years, and the patients had a history of initial injury, ongoing bouts of instability, and ratings of patient-perceived function and disability. |
| 2 | – | Diagnostic Test: y balance and SLSGroup B (Control): This group consisted of 34 matched non-affected ankles in the study. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- age sex
Key inclusion criteria (6 listed)
- Age ranged from 18 to 25 years
- The body mass index was 18.5 to 24.9 kg/m2
- History of at least one unilateral lateral ankle sprain that needed to be immobilized for three days or longer
- At least one recurring sprain in the three to six months before study participation.
- FAI if their total score is 11 or above by IdFAI.
Key exclusion criteria (7 listed)
- Previous Ankle surgery.
- Patients with bilateral ankle instability.
- Syndesmotic and medial ankle sprain .
- Severe ankle arthritis.
- Neurological disorders affect ankle function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| y balance and SLSAlso: side hopfor assessment of static and dynamic balance | Diagnostic test | 1, 2 |
Primary outcome
Arabic version of the Identification of Functional Ankle Instability questionnaire (IdFAI-AR)
Time frame: 1 session
asses of FAI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 41239273Abdelkader NA, Khafagaa MM, Aziz MZ. The gastrocnemius and soleus muscles deficits in functional ankle instability: an observational study. BMC Musculoskelet Disord. 2025 Nov 14;26(1):1046. doi: 10.1186/s12891-025-09286-4.
- Individual participant dataSharing planned: Yes
Related trials for Functional Ankle Instability
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
Recruiting
Effect of Core Stability Training With Foot Exercises in Chronic Ankle Instability Patients
Instability, Joint
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Ankle Instability, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic version of the Identification of Functional Ankle Instability questionnaire (IdFAI-AR) (time frame: 1 session). 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 NCT06715033, which also lists 1 linked publication.
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 10 Jun 2025.