Chronic Ankle InstabilityNCT04083391
Flexibility Deficit in Chronic Ankle Instability
An observational study of Chronic Ankle Instability, run by Cairo University.
Trial summary
chronic ankle instability could be associated with some proximal deficits as in hip and knee regions. these deficits include alternations in motor neurons pools excitability, muscle strength, kinematics and kinetics. this study add muscle inflexibility to the preciouse literature. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2016to 9 Mar 2017
- 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
- Healthy volunteers accepted
- Adult
Study population: Outpatients clinic faculty of physical therapy Cairo university
Who may be able to join
- The control group was self-reported to be healthy
- Had no ankle injury history
- Matched with CAI patients in gender, dominance side and simulated injured side
- CAI group had a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset which required a period of protected weight bearing and/or immobilization at least one day
- Patient reported a tendency for the ankle to give way and/or recurrent ankle sprain
- Perceives that the ankle was chronically weaker, more painful and/or less functional than the other ankle or than before first
Who cannot join
- Had a history of lower extremity injury
- Surgery or fracture
- History of low back dysfunction that required medical or surgical intervention within the last year, Current participation in formal or informal rehabilitation
- History of hamstring strain
- Bilateral ankle sprain injury
- Ankle injury within 3 months of participation
- History of ankle fracture and any neuromuscluskeletal disease could affect the condition.
About this study
Official title: Is Hamstring Flexibility Affected in Chronic Ankle Instability
chronic ankle instability could be associated with some proximal deficits as in hip and knee regions. these deficits include alternations in motor neurons pools excitability, muscle strength, kinematics and kinetics. this study add muscle inflexibility to the preciouse literature.
Read the detailed description
Background: influence of a localized injury in a distal joint on the function of proximal muscles is an important consideration in assessment and treatment of musculoskeletal injuries. Up to the investigator's knowledge, there is no study assess flexibility changes in CAI. Objectives: The objective of this study is to investigate Hamstring flexibility in CAI. Material and methods: The study conducted on 42 subjects with unilateral CAI and controls had measure of hamstring flexibility using digital inclinometer during passive knee extension test .Results: Revealed statistical and clinical significant difference between non-injured control group and CAI group with decreased hamstring flexibility in the later. Conclusion: CAI subjects have proximal muscular affection include hamstring tightness which may alter sacroiliac joint stability and subsequently back pain.
- Conditions
- Chronic Ankle Instability
- Keywords
- chronic ankle instability, Hamstring, flexibility
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 |
|---|---|---|
| CAI group | assessment had been done to this group that include patients with ankle sprain injury from more than one year and complain with repetitive injuries, giving way and instability feelings | |
| non injured ankle group | assessment had been done to this group that include control participants had not injured their ankle before and matched with CAI in age, gender, dominant side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring muscle flexibility
angle between tibia and femur during passive knee extension test
Measured: throughout the study average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start7 May 2016
- Primary completion30 Dec 2016
- Study completion9 Mar 2017
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elhady Samy Abu Mandour, Cairo University
- Investigators
- Afaf Tahoon, Master, Study chair, assistant lecturer faculty of physical therapy Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083391
- Sponsor's protocol ID
- P.T.REC/012/001312
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD had been planed to be shared with research team only through specific username and password
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Hamstring Flexibility Affected in Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04083391
- Acronym / sponsor ID
- P.T.REC/012/001312
- Conditions
- Chronic Ankle Instability
- Keywords
- chronic ankle instability, Hamstring, flexibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 May 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 10 Sep 2019 (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.
chronic ankle instability could be associated with some proximal deficits as in hip and knee regions. these deficits include alternations in motor neurons pools excitability, muscle strength, kinematics and kinetics. this study add muscle inflexibility to the preciouse literature.
Detailed description
Background: influence of a localized injury in a distal joint on the function of proximal muscles is an important consideration in assessment and treatment of musculoskeletal injuries. Up to the investigator's knowledge, there is no study assess flexibility changes in CAI. Objectives: The objective of this study is to investigate Hamstring flexibility in CAI. Material and methods: The study conducted on 42 subjects with unilateral CAI and controls had measure of hamstring flexibility using digital inclinometer during passive knee extension test .Results: Revealed statistical and clinical significant difference between non-injured control group and CAI group with decreased hamstring flexibility in the later. Conclusion: CAI subjects have proximal muscular affection include hamstring tightness which may alter sacroiliac joint stability and subsequently back pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAI group | – | –assessment had been done to this group that include patients with ankle sprain injury from more than one year and complain with repetitive injuries, giving way and instability feelings |
| non injured ankle group | – | –assessment had been done to this group that include control participants had not injured their ankle before and matched with CAI in age, gender, dominant side |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatients clinic faculty of physical therapy Cairo university
Key inclusion criteria (6 listed)
- The control group was self-reported to be healthy
- Had no ankle injury history
- Matched with CAI patients in gender, dominance side and simulated injured side
- CAI group had a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset which required a period of protected weight bearing and/or immobilization at least one day
- Patient reported a tendency for the ankle to give way and/or recurrent ankle sprain
Key exclusion criteria (7 listed)
- Had a history of lower extremity injury
- Surgery or fracture
- History of low back dysfunction that required medical or surgical intervention within the last year, Current participation in formal or informal rehabilitation
- History of hamstring strain
- Bilateral ankle sprain injury
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
Hamstring muscle flexibility
Time frame: throughout the study average 1 year
angle between tibia and femur during passive knee extension test
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 10 Sep 2019.
- Individual participant dataSharing planned: No. IPD had been planed to be shared with research team only through specific username and password
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
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Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
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Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
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.
Afaf Tahoon, Master study chair
assistant lecturer faculty of physical therapy Cairo university
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by Cairo University.
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 7 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Hamstring muscle flexibility (time frame: throughout the study average 1 year). 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 10 Sep 2019.