Ankle Sprain StrainDynamic knee vNCT06188416
Changes in Dynamic q Angle in Patients With Chronic Ankle Instability
An observational study of Ankle Sprain Strain, run by Cairo University at 1 site in Egypt.
Trial summary
This study investigates the difference in dynamic Q-angle of patients with chronic ankle instability and those without. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Ankle Sprain Strain
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2023to 3 Dec 2023
- 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 30 years
- All sexes
- Adult
Study population: The participants from both genders aged between 18 and 30 years will be divided into 2 groups: a study group and a control group. The study group consists of 52 participants with chronic ankle instability, and the control group consists of 52 participants without chronic ankle instability, normal participants with no musculoskeletal disorders or history of knee disease and no obvious limb length discrepancy.
Who may be able to join
- Subjects aged between 18 and 30 years.
- Subjects with a history of LAS for at least one year before the study onset, that required at least 1-day weight-bearing restriction.
- Subjects with a self-reported tendency of ≥2 giving way episodes during 6 months before enrollment in the study.
- Subjects with a perception that the injured ankle was chronically weaker, more painful, and/or less functional than the contralateral ankle before the first LAS.
- Subjects who scored less than 24 in the Cumberland Ankle Instability Tool (CAIT), a validated ankle instability specific questionnaire of 9 items, to determine if functional ankle instability is present.
Who cannot join
- Subjects who had bilateral LAS
- Subjects with a history of lower extremity injury, fracture, or surgery
- Subjects who participated in supervised or unsupervised ankle rehabilitation within a year before enrollment in the study
- Subjects with LAS within 3 months before participation
- Subjects with a history of knee pain during the last 6 months.
- Subjects diagnosed with knee osteoarthritis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Dokki, Giza Governorate, 12613
About this study
This study investigates the difference in dynamic Q-angle of patients with chronic ankle instability and those without.
- Conditions
- Ankle Sprain Strain
- Keywords
- Kinetic chain, Ankle instability, Q-angle
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 |
|---|---|---|
| Cases with CAI | Cases that reported previous experience of chronic ankle instability | |
| Cases without CAI | Cases that did not report any previous experience of chronic ankle instability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Q-angle
Using dynamic knee valgus through the measurement of frontal plane projection angle
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start7 Oct 2023
- Primary completion26 Nov 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain StrainStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdelmoniem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188416
- Sponsor's protocol ID
- P.T.REC/012/004802
- Acronym
- Dynamic knee v
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Dynamic q Angle in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06188416
- Acronym / sponsor ID
- Dynamic knee v / P.T.REC/012/004802
- Conditions
- Ankle Sprain Strain
- Keywords
- Kinetic chain, Ankle instability, Q-angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 3 Jan 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 investigates the difference in dynamic Q-angle of patients with chronic ankle instability and those without.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with CAI | – | –Cases that reported previous experience of chronic ankle instability |
| Cases without CAI | – | –Cases that did not report any previous experience of chronic ankle instability |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- The participants from both genders aged between 18 and 30 years will be divided into 2 groups: a study group and a control group. The study group consists of 52 participants with chronic ankle instability, and the control group consists of 52 participants without chronic ankle instability, normal participants with no musculoskeletal disorders or history of knee disease and no obvious limb length discrepancy.
Key inclusion criteria (5 listed)
- Subjects aged between 18 and 30 years.
- Subjects with a history of LAS for at least one year before the study onset, that required at least 1-day weight-bearing restriction.
- Subjects with a self-reported tendency of ≥2 giving way episodes during 6 months before enrollment in the study.
- Subjects with a perception that the injured ankle was chronically weaker, more painful, and/or less functional than the contralateral ankle before the first LAS.
- Subjects who scored less than 24 in the Cumberland Ankle Instability Tool (CAIT), a validated ankle instability specific questionnaire of 9 items, to determine if functional ankle instability is present.
Key exclusion criteria (6 listed)
- Subjects who had bilateral LAS
- Subjects with a history of lower extremity injury, fracture, or surgery
- Subjects who participated in supervised or unsupervised ankle rehabilitation within a year before enrollment in the study
- Subjects with LAS within 3 months before participation
- Subjects with a history of knee pain during the last 6 months.
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
Dynamic Q-angle
Time frame: 6 months
Using dynamic knee valgus through the measurement of frontal plane projection angle
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 3 Jan 2024.
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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 Ankle Sprain Strain, 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 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 3 Jan 2024. 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?
Dynamic Q-angle (time frame: 6 months). 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 Jan 2024.