Chronic Ankle InstabilityNCT05676125
Trunk Muscle Strength and Endurance in Chronic Ankle Instability
An observational study of Chronic Ankle Instability, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of trunk muscle strength in patients of chronic ankle instability Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Jan 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
- Women only
- Adult
Study population: faculty of physical therapy outpatient clinic
Who may be able to join
- The initial sprain must have occurred at least 12 months prior to study enrollment.
- The most recent injury must have occurred more than three months prior to study enrollment (unassisted walking without limping for at least three months after injury).
- A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability.
- The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle.
- The Oswesty Disability Index (ODI) score for both groups is from 0 to 20% (minimal disability) (Fairbank and Pynsent, 2000).
- 6- The Identification of Functional Ankle Instability questionnaire (IdFAI) score is less than 10 for the experimental group and 11 or more for the control group (Simon et al., 2012).
Who cannot join
- 1-A history of previous surgeries or fractures in either limb of lower extremity.
- 2-Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.
- 3-Any positive findings of the anterior drawer or talar tilt test (Hubbard and Kaminski, 2002).
- 4-Any shoulder (Kibler et al., 2006) or elbow injuries (Ben Kibler and Sciascia, 2004).
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of trunk muscle strength in patients of chronic ankle instability
Read the detailed description
This study will be conducted in the Isokinetic Laboratory. Sixty females with CAI will participate in this study. Their age will range from 18-30 years. They will be divided into two groups; the experimental and the control group. The experimental group will involve 30 females with CAI and the control group will involve 30 healthy females. The isokinetic strength of trunk muscles will be evaluated in a concentric mode of muscle contraction at an angular velocity 60°/sec. McGill test will be used to assess trunk muscle endurance.
- Conditions
- Chronic Ankle Instability
- Keywords
- CAI
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 |
|---|---|---|
| chronic ankle instabilty group | females with previous history of ankle sprain | |
| control group | healthy feamles |
What is being measured
The primary outcome is the main question the study is designed to answer.
trunk muscles strength
concentric peak torque of trunk flexors and extensors
Measured: this will be evaluated on day one
core muscle endurance
mcgill core endurance tests
Measured: this will be evaluated on day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, noha mahmoud youssef aboelezz, Cairo University
- Investigators
- salam M Elhafez, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676125
- Sponsor's protocol ID
- P.T.REC/012/003263
- Status last verified
- Aug 2023
- First submitted
- 22 Dec 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Muscle Strength and Endurance in Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05676125
- Acronym / sponsor ID
- P.T.REC/012/003263
- Conditions
- Chronic Ankle Instability
- Keywords
- CAI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 Jan 2023 (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.
Evaluation of trunk muscle strength in patients of chronic ankle instability
Detailed description
This study will be conducted in the Isokinetic Laboratory. Sixty females with CAI will participate in this study. Their age will range from 18-30 years. They will be divided into two groups; the experimental and the control group. The experimental group will involve 30 females with CAI and the control group will involve 30 healthy females. The isokinetic strength of trunk muscles will be evaluated in a concentric mode of muscle contraction at an angular velocity 60°/sec. McGill test will be used to assess trunk muscle endurance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic ankle instabilty group | – | –females with previous history of ankle sprain |
| control group | – | –healthy feamles |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- faculty of physical therapy outpatient clinic
Key inclusion criteria (6 listed)
- The initial sprain must have occurred at least 12 months prior to study enrollment.
- The most recent injury must have occurred more than three months prior to study enrollment (unassisted walking without limping for at least three months after injury).
- A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability.
- The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle.
- The Oswesty Disability Index (ODI) score for both groups is from 0 to 20% (minimal disability) (Fairbank and Pynsent, 2000).
Key exclusion criteria (4 listed)
- 1-A history of previous surgeries or fractures in either limb of lower extremity.
- 2-Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.
- 3-Any positive findings of the anterior drawer or talar tilt test (Hubbard and Kaminski, 2002).
- 4-Any shoulder (Kibler et al., 2006) or elbow injuries (Ben Kibler and Sciascia, 2004).
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
trunk muscles strength
Time frame: this will be evaluated on day one
concentric peak torque of trunk flexors and extensors
core muscle endurance
Time frame: this will be evaluated on day one
mcgill core endurance tests
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 31 Aug 2023.
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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.
salam M Elhafez, Professor study director
Cairo University
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 6 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 31 Aug 2023. 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?
trunk muscles strength (time frame: this will be evaluated on day one). 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 31 Aug 2023.