Chronic Ankle Instability, CAINCT06925191
Assessment of Torso Musculature and Hamstring Flexibility in Patients With Chronic Ankle Instability
An observational study of Chronic Ankle Instability, CAI, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess torso musculature in terms of static and dynamic core muscle endurance tests and hamstring flexibility in non-athletic patients with unilateral chronic ankle instability. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability, CAI
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2024to 15 Mar 2025
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 29 healthy people and 29 non-healthy people with chronic ankle instability
Who may be able to join
- Inclusion criteria was based on the standard criteria outlined by the International Ankle Consortium (Gribble et al., 2014).
- Their ages range from 20- 35 years old including both genders (male \& female).
- Their BMI was 18.5- 30 kg/m2.
- A history of the previously injured ankle joint "giving way," and/or recurrent sprain, and/or "feelings of instability."
- Report episodes of giving way and sense of instability of the affected ankle
- Cumberland Ankle Instability Tool (CAIT) patient scores < 24.
Who cannot join
- Subjects were excluded if they have any of the following criteria:( Gribble et al., 2014).
- A history of previous surgeries on the musculoskeletal structures (i.e., bones, joint structures, nerves) in either lower extremity.
- A history of a fracture in either lower extremity requiring realignment.
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (i.e., sprains, fractures), resulting in at least 1 interrupted day of desired physical activity.
- Any patient received physical therapy treatment or medical treatment (NSAID)in the last 2weeks Before enrollment in the study.
- Any patients suffered from low back pain, lumbar disorder and Sacro iliac joint pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Hamstring Flexibility, Static and Dynamic Core Muscles Endurance in Patients With Chronic Ankle Instability
The purpose of this study is to assess torso musculature in terms of static and dynamic core muscle endurance tests and hamstring flexibility in non-athletic patients with unilateral chronic ankle instability.
Read the detailed description
Ankle sprains are extremely common in public as well as in sports. Most people with acute ankle sprains respond well to conservative treatment , but many may experience chronic ankle pain and instability .
Injuries to the ankle lateral ligament typically occur when the ankle joint is inverted and plantar flexed . Ankle sprains occur about seven times per 1000 person-years in the general population, and in highly active people, the incidence can reach 45 times per 1000 person-years .
Chronic ankle instability (CAI), which includes both functional and mechanical ankle instability, is characterized by recurrent ankle sprains, persistent symptoms, and a tendency to "giving way" .
The terms mechanical ankle instability (MAI) and functional ankle instability (FAI) refer to two different conditions: FAI is defined as recurrent ankle sprains or re-damage, while MAI is defined as a state of ligament relaxation detected by objective physical examinations of the talar tilt and anterior drawer sign. The complaint of subjective feelings, such as ankle giving away in FI, is associated with FAI .
In relation to postural stability, which is characterized as the capacity to sustain and regulate one's center of gravity over a support base, postural control is a complicated process that arises from the cooperation and synergy of the vestibular, ocular, and somatosensory systems. Moreover, lower limb injuries are thought to be associated with postural instability.
In the kinetic chain that runs from the foot to the lumbar spine, core stability has been emphasized as a crucial factor to keep in mind when preserving dynamic joint stability .
It is important to note that in this instance, core stability refers to the hip complex's ability to maintain homeostasis following a disturbance and to avoid buckling. Additionally, there is clear evidence linking lower limb movement to trunk muscle activity . Motor chain disruptions resulting from dysfunction in the trunk, pelvis, and hips can cause lower extremity injuries and lower back pain (LBP) .
Additionally, the torso musculature was measured by testing the endurance of the core muscles (static and dynamic). The Bench Trunk Curl-Up test (BTCT) was used to measure dynamic endurance, while the modified right side-bridge, modified left side-bridge, trunk flexion and horizontal back extension tests were used for static endurance (the endurance time of each isometric test was recorded).
In addition to disorders including low back discomfort and irregular gait, tight hamstrings are linked to dysfunction in the lumbar spine, pelvis, and lower limb .
Tight hamstrings are linked to poor motor control patterns, which compromise postural muscle activation and make the hamstrings function more as stabilizers than as main movers. Hamstring tightness manifests because of this basic change in function .
Numerous research has assessed CAI's proximal deficiencies. A few evaluated their strength , and excitability Moreover, alterations in kinematics have been evaluated .
Statement of the problem
This study will try to answer the following question:
Are torso musculature and hamstring flexibility affected in non-athletic patients with unilateral chronic ankle instability? Purpose of the study The purpose of this study is to assess torso musculature in terms of static and dynamic core muscle endurance tests and hamstring flexibility in non-athletic patients with unilateral chronic ankle instability.
Hypotheses
It will be hypothesized that:
- There is no significant difference in torso musculature in terms of static core muscle endurance between non-athletic healthy participants and non-athletic patients with unilateral chronic ankle instability.
- There is no significant difference in torso musculature in terms of dynamic core muscle endurance between healthy participants and non-athletic patients with unilateral chronic ankle instability.
- There is no significant difference in hamstring flexibility between non-athletic healthy participants and non-athletic patients with unilateral chronic ankle instability.
Significance of study Lateral ankle sprain is one of the most common sports injuries, and it has the highest recurrence rate among all lower-extremity musculoskeletal injuries .
chronic ankle instability (CAI) is linked to a lower lifetime quality of life, a lower degree of physical activity, and a higher chance of developing osteoarthritis in the joints .
Ankle sprains occurred 3.29 times per 1000 people annually in US emergency rooms in 2010 . The prevalence of CAI after a sprain is 25% overall, and in otherwise healthy adolescent athletes, it is 20% after an ankle sprain, even though over 15% of cases result in CAI, the public still views ankle sprains as benign injuries .
Hip muscle abnormalities are becoming more common in CAI patients, as described in studies , which might worsen the condition by impairing trunk and pelvic stability and causing the lower body to be malposition as a result .
Reduced lumbopelvic stability may theoretically exacerbate CAI, however this association is still theoretical. Tests that test a person's capacity to maintain hip and trunk alignment can be used to assess lumbar stability. However, no research has up to this point compared to the performance levels of those with and without CAI. Additionally, muscle deficiencies in the hip and trunk can impact lumbopelvic stability. There is, however, a lack of data on the anatomy of the trunk muscles in patients with CAI .
According to previous research, those with CAI experience higher rates of low back pain , delayed trunk muscle activation.
Previous study has investigated the relationship between core stability (CS) and CAI and concluded that, the lack of a clear correlation between trunk endurance and CAI remains unclear; nevertheless, it's possible that the McGill core endurance tests don't accurately assess lumbo-pelvic stability in CAI patients or distinguish between those who have the condition from those who don't. The individuals' sensorimotor systems were not sufficiently challenged by the tests to identify variations between groups. These tests only evaluate the static core endurance.
Therefore, it is crucial to assess torso musculature with CAI for both genders by both static and dynamic core endurance as This facilitates prevention of injury and management of the associated musculoskeletal deficits of CAI.
Previous research evaluating the Arthrogenic Muscle Response of the Hamstrings and Quadriceps with Chronic Ankle Instability produced the conclusion that participants with unilateral CAI had ipsilateral facilitation of the quadriceps and bilateral arthrogenic inhibition of the hamstrings. The motoneuron pool excitability in muscles acting on joints proximal to the ankle seems to be changed in individuals with unilateral CAI. Furthermore, deficiencies in sagittal plane force production were noted at the ankle and the knee, even though the source of instability was at the ankle.
The knee flexor muscles' maximal and submaximal isometric strengths as well as the knee extensor muscles' submaximal strengths are abnormal in people with CAI.
Previous studies assessed hamstring flexibility in ankle sprain or CAI in order to orient the therapist to evaluate the proximal affection that far from the injured site that influencing both preventative and therapeutic approaches to patient care, subsequently completing the evaluation procedures, reduce recurrence rate, restore functional loss and prevent degenerative sequels and concluded that CAI subjects have proximal muscular affection include hamstring tightness which may alter sacroiliac joint stability and subsequently back pain .
- Conditions
- Chronic Ankle Instability, CAI
- Being tested
- Group A (Experimental): 29 affected ankles of both genders diagnosed with Chronic ankle instability (CAI) who met the inclusion criteria. Group B (Control): 29 matched non-affected with CAI
- Keywords
- hamstring flexibility, 90-90 active knee extension, torso musculature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Experimental): 29 affected ankles of both genders diagnosed with Chronic ankle instability (CAI) who met the inclusion criteria. Group B (Control): 29 matched non-affected with CAIDiagnostic test
1-90-90Active knee extension test 2.Core muscles endurance tests(a. The static endurance tests b. The dynamic endurance tests)
Time Frame: 1 session
What is being measured
The primary outcome is the main question the study is designed to answer.
90-90Active knee extension test
The angle of knee extension was measured in degrees by a standard goniometer while the patient in supine position and the hip was in 90 degrees of hip flexion
Measured: 1 session
Secondary outcomes (1)
Static Core muscles endurance tests
- Modified Right side-bridge test was measured in second by stopwatch while the patient was told to lie on her right side with their right hip and elbow (which were flexed to a 90-degree angle) supporting their right side and their hips were elevated off the table.
- (Modified Left side-bridge test) The same procedures were repeated but for the left side
- Trunk flexors endurance test was measured in second by stopwatch while the patient was instructed to place her body against a wedge at a neutral head position, 90° hip and knee flexion, and 60° trunk flexion to begin the test. Each person had their arms folded across their chests. The examiner then shifted the wedge aside and gave the subject instructions to maintain her posture without using her back support
- Modified Biering-Sorensen test was measured in second by stopwatch while the patient was in prone position, supporting their lower legs on the table while maintaining their trunk straight out of the table .
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 posted13 Apr 2025
- Study start2 Nov 2024
- Primary completion27 Feb 2025
- Study completion15 Mar 2025
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Ahmed Abdelaziz Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925191
- Sponsor's protocol ID
- P.T.REC/012/005526
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hamstring Flexibility, Static and Dynamic Core Muscles Endurance in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06925191
- Acronym / sponsor ID
- P.T.REC/012/005526
- Conditions
- Chronic Ankle Instability, CAI
- Keywords
- hamstring flexibility, 90-90 active knee extension, torso musculature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 13 Apr 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 assess torso musculature in terms of static and dynamic core muscle endurance tests and hamstring flexibility in non-athletic patients with unilateral chronic ankle instability.
Detailed description
Ankle sprains are extremely common in public as well as in sports. Most people with acute ankle sprains respond well to conservative treatment , but many may experience chronic ankle pain and instability .
Injuries to the ankle lateral ligament typically occur when the ankle joint is inverted and plantar flexed . Ankle sprains occur about seven times per 1000 person-years in the general population, and in highly active people, the incidence can reach 45 times per 1000 person-years .
Chronic ankle instability (CAI), which includes both functional and mechanical ankle instability, is characterized by recurrent ankle sprains, persistent symptoms, and a tendency to "giving way" .
The terms mechanical ankle instability (MAI) and functional ankle instability (FAI) refer to two different conditions: FAI is defined as recurrent ankle sprains or re-damage, while MAI is defined as a state of ligament relaxation detected by objective physical examinations of the talar tilt and anterior drawer sign. The complaint of subjective feelings, such as ankle giving away in FI, is associated with FAI .
In relation to postural stability, which is characterized as the capacity to sustain and regulate one's center of gravity over a support base, postural control is a complicated process that arises from the cooperation and synergy of the vestibular, ocular, and somatosensory systems. Moreover, lower limb injuries are thought to be associated with postural instability.
In the kinetic chain that runs from the foot to the lumbar spine, core stability has been emphasized as a crucial factor to keep in mind when preserving dynamic joint stability .
It is important to note that in this instance, core stability refers to the hip complex's ability to maintain homeostasis following a disturbance and to avoid buckling. Additionally, there is clear evidence linking lower limb movement to trunk muscle activity . Motor chain disruptions resulting from dysfunction in the trunk, pelvis, and hips can cause lower extremity injuries and lower back pain (LBP) .
Additionally, the torso musculature was measured by testing the endurance of the core muscles (static and dynamic). The Bench Trunk Curl-Up test (BTCT) was used to measure dynamic endurance, while the modified right side-bridge, modified left side-bridge, trunk flexion and horizontal back extension tests were used for static endurance (the endurance time of each isometric test was recorded).
In addition to disorders including low back discomfort and irregular gait, tight hamstrings are linked to dysfunction in the lumbar spine, pelvis, and lower limb .
Tight hamstrings are linked to poor motor control patterns, which compromise postural muscle activation and make the hamstrings function more as stabilizers than as main movers. Hamstring tightness manifests because of this basic change in function .
Numerous research has assessed CAI's proximal deficiencies. A few evaluated their strength , and excitability Moreover, alterations in kinematics have been evaluated .
Statement of the problem
This study will try to answer the following question:
Are torso musculature and hamstring flexibility affected in non-athletic patients with unilateral chronic ankle instability? Purpose of the study The purpose of this study is to assess torso musculature in terms of static and dynamic core muscle endurance tests and hamstring flexibility in non-athletic patients with unilateral chronic ankle instability.
Hypotheses
It will be hypothesized that:
- There is no significant difference in torso musculature in terms of static core muscle endurance between non-athletic healthy participants and non-athletic patients with unilateral chronic ankle instability.
- There is no significant difference in torso musculature in terms of dynamic core muscle endurance between healthy participants and non-athletic patients with unilateral chronic ankle instability.
- There is no significant difference in hamstring flexibility between non-athletic healthy participants and non-athletic patients with unilateral chronic ankle instability.
Significance of study Lateral ankle sprain is one of the most common sports injuries, and it has the highest recurrence rate among all lower-extremity musculoskeletal injuries .
chronic ankle instability (CAI) is linked to a lower lifetime quality of life, a lower degree of physical activity, and a higher chance of developing osteoarthritis in the joints .
Ankle sprains occurred 3.29 times per 1000 people annually in US emergency rooms in 2010 . The prevalence of CAI after a sprain is 25% overall, and in otherwise healthy adolescent athletes, it is 20% after an ankle sprain, even though over 15% of cases result in CAI, the public still views ankle sprains as benign injuries .
Hip muscle abnormalities are becoming more common in CAI patients, as described in studies , which might worsen the condition by impairing trunk and pelvic stability and causing the lower body to be malposition as a result .
Reduced lumbopelvic stability may theoretically exacerbate CAI, however this association is still theoretical. Tests that test a person's capacity to maintain hip and trunk alignment can be used to assess lumbar stability. However, no research has up to this point compared to the performance levels of those with and without CAI. Additionally, muscle deficiencies in the hip and trunk can impact lumbopelvic stability. There is, however, a lack of data on the anatomy of the trunk muscles in patients with CAI .
According to previous research, those with CAI experience higher rates of low back pain , delayed trunk muscle activation.
Previous study has investigated the relationship between core stability (CS) and CAI and concluded that, the lack of a clear correlation between trunk endurance and CAI remains unclear; nevertheless, it's possible that the McGill core endurance tests don't accurately assess lumbo-pelvic stability in CAI patients or distinguish between those who have the condition from those who don't. The individuals' sensorimotor systems were not sufficiently challenged by the tests to identify variations between groups. These tests only evaluate the static core endurance.
Therefore, it is crucial to assess torso musculature with CAI for both genders by both static and dynamic core endurance as This facilitates prevention of injury and management of the associated musculoskeletal deficits of CAI.
Previous research evaluating the Arthrogenic Muscle Response of the Hamstrings and Quadriceps with Chronic Ankle Instability produced the conclusion that participants with unilateral CAI had ipsilateral facilitation of the quadriceps and bilateral arthrogenic inhibition of the hamstrings. The motoneuron pool excitability in muscles acting on joints proximal to the ankle seems to be changed in individuals with unilateral CAI. Furthermore, deficiencies in sagittal plane force production were noted at the ankle and the knee, even though the source of instability was at the ankle.
The knee flexor muscles' maximal and submaximal isometric strengths as well as the knee extensor muscles' submaximal strengths are abnormal in people with CAI.
Previous studies assessed hamstring flexibility in ankle sprain or CAI in order to orient the therapist to evaluate the proximal affection that far from the injured site that influencing both preventative and therapeutic approaches to patient care, subsequently completing the evaluation procedures, reduce recurrence rate, restore functional loss and prevent degenerative sequels and concluded that CAI subjects have proximal muscular affection include hamstring tightness which may alter sacroiliac joint stability and subsequently back pain .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 29 healthy people and 29 non-healthy people with chronic ankle instability
Key inclusion criteria (6 listed)
- Inclusion criteria was based on the standard criteria outlined by the International Ankle Consortium (Gribble et al., 2014).
Key exclusion criteria (6 listed)
- Subjects were excluded if they have any of the following criteria:( Gribble et al., 2014).
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 |
|---|---|---|
| Group A (Experimental): 29 affected ankles of both genders diagnosed with Chronic ankle instability (CAI) who met the inclusion criteria. Group B (Control): 29 matched non-affected with CAI1-90-90Active knee extension test 2.Core muscles endurance tests(a. The static endurance tests b. The dynamic endurance tests) Time Frame: 1 session | Diagnostic test | – |
Primary outcome
90-90Active knee extension test
Time frame: 1 session
The angle of knee extension was measured in degrees by a standard goniometer while the patient in supine position and the hip was in 90 degrees of hip flexion
1 secondary outcome
Static Core muscles endurance tests
Time frame: 1 session
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 13 Apr 2025.
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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. 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 Chronic Ankle Instability, CAI, 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 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: finished, as of the sponsor's last update on 13 Apr 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?
90-90Active knee extension test (time frame: 1 session). 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 13 Apr 2025.