Chronic Ankle InstabilityDKV/CAINCT07121725
Relationship of Dynamic Knee Valgus With Foot Posture, Pain, and Balance in Chronic Ankle Instability.
An observational study of Chronic Ankle Instability, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to identify if there is a relationship between the frontal plane projection angle as a measure of dynamic knee valgus with foot posture, pain, and dynamic balance in chronic ankle instability patients. Read more about this study
- Who is it for?
- Ages 15 to 32 years
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Apr 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 15 to 32 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The sample will be recruited from the outpatient clinic of the Faculty of Physical Therapy at Cairo University by referral from the orthopedic doctor diagnosed with chronic ankle instability.
Who may be able to join
- A history of at least 1 significant ankle sprain.
- The initial sprain must have occurred at least 12 months prior to study enrollment.
- The most recent injury must have occurred more than 3 months prior.
- Additionally, a sprain that was associated with inflammatory symptoms (pain, swelling, etc.), Created at least 1 interrupted day of desired physical activity.
- A history of the previously injured ankle joint as "giving way" and/or recurrent sprain and/or "feelings of instability." And the self-reported outcome measure foot and ankle ability measure (FAAM): ADL scale <90%.
Who cannot join
- History of previous surgeries or fractures to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either limb.
- No acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity.
- Participants were screened to exclude scoliosis using the Adam's Forward Bend Test (AFBT).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to identify if there is a relationship between the frontal plane projection angle as a measure of dynamic knee valgus with foot posture, pain, and dynamic balance in chronic ankle instability patients.
Read the detailed description
The study design is an observational, correlational study to find if there is any relationship between the frontal plane projection angle with foot posture, pain, and dynamic balance in chronic ankle instability non-athletic patients.
The sample size is estimated to be 84. The frontal plane projection angle will be measured using a single-leg squat test and analyzed using Kinovea software.
Foot posture will be measured using the foot posture index. pain will be measured using a numerical rating scale. dynamic balance will be measured using modified star excursion balance tets
- Conditions
- Chronic Ankle Instability
- Keywords
- Frontal plane projection angle
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the frontal plane projection angle and foot posture in chronic ankle instability patients.
NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle"
UNIT OF MEASURE: "measured in degrees"
MEASUREMENT TOOL: "using a digital camera and Kinovea software"
regarding foot posture:
NAME OF THE MEASUREMENT: "Foot Posture"
MEASUREMENT TOOL: "assessed using the Foot Posture Index (FPI), a 6-item scale" Criteria assessed included palpating the talar head, assessing supra and infra lateral malleolar curvature, calcaneal inversion/eversion, and examining talo-navicular prominence. Additionally, the congruence of the medial longitudinal arch and the forefoot's abduction/adduction relative to the rearfoot was evaluated
UNIT OF MEASURE: "scored from -12 to +12
- Highly supinated foot scores between (-5 to -12)
- Supinated foot scores between (-4 to -1)
- Normal foot scores between (0 to +5)
- Pronated foot scores between (+6 to +9)
- Highly pronated foot scores between (+10 to +12).
Measured: baseline (single assessment session)
correlation between the frontal plane projection angle and pain in chronic ankle instability patients
regarding the frontal plane projection angle:
NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle"
UNIT OF MEASURE: "measured in degrees"
MEASUREMENT TOOL: "using a digital camera and Kinovea software"
regarding pain measurement: NAME OF THE MEASUREMENT: Pain Intensity
UNIT OF MEASURE:
scale extending from 0 to 10 where 0 represented "no pain" and 10 represented the "worst pain possible''
MEASUREMENT TOOL: 11-point Numeric Rating Scale (NRS-11)
Measured: baseline (single assessment session)
correlation between the frontal plane projection angle and dynamic balance in chronic ankle instability patients.
regarding the frontal plane projection angle:
NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle"
UNIT OF MEASURE: "measured in degrees"
MEASUREMENT TOOL: "using a digital camera and Kinovea software"
regarding dynamic balance:
NAME OF THE MEASUREMENT: "Dynamic Balance"
MEASUREMENT TOOL: "Modified Star Excursion Balance Test (M-SEBT)"
UNIT OF MEASURE: "normalized reach distance in centimeters (cm)
Measured: baseline (single assessment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Dec 2024
- Primary completion28 Feb 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meriam Nasser William Shafik, Cairo University
- Investigators
- Meriam N Shafik, B.Sc, Principal investigator, department of musculoskeletal disorders and it's surgery- Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121725
- Sponsor's protocol ID
- No:P.T.REC/012/005728
- Acronym
- DKV/CAI
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Dynamic Knee Valgus With Foot Posture, Pain, and Balance in Chronic Ankle Instability.
- ClinicalTrials.gov ID
- NCT07121725
- Acronym / sponsor ID
- DKV/CAI / No:P.T.REC/012/005728
- Conditions
- Chronic Ankle Instability
- Keywords
- Frontal plane projection angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 13 Aug 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 the study is to identify if there is a relationship between the frontal plane projection angle as a measure of dynamic knee valgus with foot posture, pain, and dynamic balance in chronic ankle instability patients.
Detailed description
The study design is an observational, correlational study to find if there is any relationship between the frontal plane projection angle with foot posture, pain, and dynamic balance in chronic ankle instability non-athletic patients.
The sample size is estimated to be 84. The frontal plane projection angle will be measured using a single-leg squat test and analyzed using Kinovea software.
Foot posture will be measured using the foot posture index. pain will be measured using a numerical rating scale. dynamic balance will be measured using modified star excursion balance tets
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The sample will be recruited from the outpatient clinic of the Faculty of Physical Therapy at Cairo University by referral from the orthopedic doctor diagnosed with chronic ankle instability.
Key inclusion criteria (5 listed)
- A history of at least 1 significant ankle sprain.
- The initial sprain must have occurred at least 12 months prior to study enrollment.
- The most recent injury must have occurred more than 3 months prior.
- Additionally, a sprain that was associated with inflammatory symptoms (pain, swelling, etc.), Created at least 1 interrupted day of desired physical activity.
- A history of the previously injured ankle joint as "giving way" and/or recurrent sprain and/or "feelings of instability." And the self-reported outcome measure foot and ankle ability measure (FAAM): ADL scale <90%.
Key exclusion criteria (3 listed)
- History of previous surgeries or fractures to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either limb.
- No acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity.
- Participants were screened to exclude scoliosis using the Adam's Forward Bend Test (AFBT).
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
correlation between the frontal plane projection angle and foot posture in chronic ankle instability patients.
Time frame: baseline (single assessment session)
NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle" UNIT OF MEASURE: "measured in degrees" MEASUREMENT TOOL: "using a digital camera and Kinovea software" regarding foot posture: NAME OF THE MEASUREMENT: "Foot Posture" MEASUREMENT TOOL: "assessed using the Foot Posture Index (FPI), a 6-item scale" Criteria assessed included palpating the talar head, assessing supra and infra lateral malleolar curvature, calcaneal inversion/eversion, and examining talo-navicular prominence. Additionally, the congruence of the medial longitudinal arch and the forefoot's abduction/adduction relative to the rearfoot was evaluated UNIT OF MEASURE: "scored from -12 to +12 * Highly supinated foot scores between (-5 to -12) * Supinated foot scores between (-4 to -1) * Normal foot scores between (0 to +5) * Pronated foot scores between (+6 to +9) * Highly pronated foot scores between (+10 to +12).
correlation between the frontal plane projection angle and pain in chronic ankle instability patients
Time frame: baseline (single assessment session)
regarding the frontal plane projection angle: NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle" UNIT OF MEASURE: "measured in degrees" MEASUREMENT TOOL: "using a digital camera and Kinovea software" regarding pain measurement: NAME OF THE MEASUREMENT: Pain Intensity UNIT OF MEASURE: scale extending from 0 to 10 where 0 represented "no pain" and 10 represented the "worst pain possible'' MEASUREMENT TOOL: 11-point Numeric Rating Scale (NRS-11)
correlation between the frontal plane projection angle and dynamic balance in chronic ankle instability patients.
Time frame: baseline (single assessment session)
regarding the frontal plane projection angle: NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle" UNIT OF MEASURE: "measured in degrees" MEASUREMENT TOOL: "using a digital camera and Kinovea software" regarding dynamic balance: NAME OF THE MEASUREMENT: "Dynamic Balance" MEASUREMENT TOOL: "Modified Star Excursion Balance Test (M-SEBT)" UNIT OF MEASURE: "normalized reach distance in centimeters (cm)
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 Aug 2025.
- 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. This study is not recruiting at the moment.
Meriam N Shafik, B.Sc principal investigator
department of musculoskeletal disorders and it's surgery- Faculty of Physical Therapy
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, 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 5 inclusion and 3 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 Aug 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?
correlation between the frontal plane projection angle and foot posture in chronic ankle instability patients. (time frame: baseline (single assessment session)). The study lists 3 primary outcomes in all. 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 Aug 2025.