AssessmentNCT04706351
Arabic Version of Identification of Functional Ankle Instability Questionnaire
An observational study of Assessment, run by Cairo University at 1 site in Egypt.
Trial summary
Testing the validity and reliability of IdFAI Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Assessment
- What is being tested?
- IdFAI questionnaire
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2018to 22 Jan 2020
- 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 24 years
- All sexes
- Adult
Study population: male and female college students
Who may be able to join
- eighty six male and female college students will voluntarily participate in the study
Who cannot join
- Previous ankle surgery.
- History of any ankle surgery.
- History of fracture within the last 6 months.
- Been involved in any previous strengthening or athletic training program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Arabic Version of Identification of Functional Ankle Instability Questionnaire(IdFAI-Ar)
Testing the validity and reliability of IdFAI
Read the detailed description
reliability \& validity of Identification Functional Ankle Instability Questionnaire (IdFAI) Arabic version were assessed in reference to Lower Extremity Functional Scale among repeated ankle sprains college students in Cairo. These college students were randomly selected from different colleges in Cairo University
- Conditions
- Assessment
- Being tested
- IdFAI questionnaire
- Keywords
- Arabic, questionnaire, ankell instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdFAI questionnaireOther
The Identification of Functional Ankle Instability (IdFAI) is a newly published questionnaire that was specifically designed to detect whether individuals meet a minimum criteria necessary for inclusion in an FAI population. The IdFAI is intended to give both researchers and clinicians a simple and effective tool to determine an individual's ankle stability status
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
Correlation coefficient
Measured: 3 months
Reliability
Cronbach's Alpha
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start10 Mar 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AssessmentStudies 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
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdelhamied Mohamed Khalil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706351
- Sponsor's protocol ID
- P.T REC/012/001829
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 27 Jan 2021
- 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Arabic Version of Identification of Functional Ankle Instability Questionnaire(IdFAI-Ar)
- ClinicalTrials.gov ID
- NCT04706351
- Acronym / sponsor ID
- P.T REC/012/001829
- Conditions
- Assessment
- Keywords
- Arabic, questionnaire, ankell instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 12 Jan 2021 (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.
Testing the validity and reliability of IdFAI
Detailed description
reliability \& validity of Identification Functional Ankle Instability Questionnaire (IdFAI) Arabic version were assessed in reference to Lower Extremity Functional Scale among repeated ankle sprains college students in Cairo. These college students were randomly selected from different colleges in Cairo University
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Age groups
- Adult
- Study population
- male and female college students
Key inclusion criteria (1 listed)
- eighty six male and female college students will voluntarily participate in the study
Key exclusion criteria (4 listed)
- Previous ankle surgery.
- History of any ankle surgery.
- History of fracture within the last 6 months.
- Been involved in any previous strengthening or athletic training program.
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 |
|---|---|---|
| IdFAI questionnaireThe Identification of Functional Ankle Instability (IdFAI) is a newly published questionnaire that was specifically designed to detect whether individuals meet a minimum criteria necessary for inclusion in an FAI population. The IdFAI is intended to give both researchers and clinicians a simple and effective tool to determine an individual's ankle stability status | Other | – |
Primary outcome
Validity
Time frame: 3 months
Correlation coefficient
Reliability
Time frame: 3 months
Cronbach's Alpha
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 27 Jan 2021.
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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 Assessment, 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 1 inclusion and 4 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 27 Jan 2021. 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?
Validity (time frame: 3 months). The study lists 2 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 27 Jan 2021.