Complete Tear, Ankle, Lateral LigamentNCT04788225
Assessment of Balance and Function After Lateral Ankle Ligament Repair
An observational study of Complete Tear, Ankle, Lateral Ligament and Postural Balance, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Approximately 85% of ankle injuries are lateral region injuries.Surgical repair of lateral ligaments is indicated if there is more than 20 degrees of varus or more than 15 mm translation, if conservative treatment is ineffective and degree of damage is high and chronic instability has developed.After the surgery in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Tear, Ankle, Lateral Ligament, Postural Balance, Physical Functional Performance
- What is being tested?
- Balance assessment, Functionality assessment and Performance assessment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2021to 1 Feb 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have undergone ATFL repair surgery at Gazi University Hospital The healthy control group will consist of patient relatives or volunteers to participate in the study.
Who may be able to join
- Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Volunteer to participate in the study
Who cannot join
- Any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder, history of fracture and surgical operation of the lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inci Ayas
Ankara, 06560
inci ayas, 03122162621, inciayass@gmail.com
seyit çıtaker, 03122162621, scitaker@gazi.edu.tr
About this study
Approximately 85% of ankle injuries are lateral region injuries.Surgical repair of lateral ligaments is indicated if there is more than 20 degrees of varus or more than 15 mm translation, if conservative treatment is ineffective and degree of damage is high and chronic instability has developed.After the surgery in addition to pain and edema control, weight transfer is not performed on the ankle for 6 weeks.Therefore, this process may adversely affect the muscle strength and range of motion of the ankle, and lower extremity performance and muscular synergies of balance.Although pathological changes caused by ligament damage have been investigated very well in the literature, it is not clear how surgical repair affects these changes. In our study we aim to investigate post-surgical changes.
Primary aim of the study is to evaluate the balance parameters of individuals who have undergone anterior talofibular ligament and / or calcaneofibular ligament repair, and its secondary purpose is to evaluate lower extremity performance, ankle functionality, pain, range of motion and muscle strength and compare them with healthy individuals.
Our hypothesis is that the balance, lower extremity performance and functionality, pain, range of motion and muscle strength of patients who have undergone ankle lateral ligament repair are worse than healthy individuals.
- Being tested
- Balance assessment, Functionality assessment, Performance assessment, ROM assessment
- Keywords
- Lateral ankle ligaments repair, Postural Balance, Physical Functional Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance assessmentOther
Also called Clinical assessment
Static balances will be measured with the Biodex-BioSway 950-462 static balance device according to 3 different standard test procedures (Postural Stability Test, Stability Limit Test and Modified Sensori Organization Test) in single foot stance and double foot stance.
Dynamic balances will be evaluated with the Y balance test.
Functionality assessmentOther
Also called Clinical assessment
Functionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)
Performance assessmentOther
Also called Clinical assessment
Performance evaluation will be made with a single leg jump test and time up and go test.
ROM assessmentOther
Also called Clinical assessment
Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ATFL repair by arthroscopic method | Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Between the ages of 18-65 Volunteer to participate in the study Without any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder No history of fracture and surgical operation of the lower extremity Receives: Other: Balance assessment; Other: Functionality assessment; Other: Performance assessment; Other: ROM assessment | |
| Control group | Between the ages of 18-65 Volunteer to participate in the study Healthy individuals with no disease Receives: Other: Balance assessment; Other: Functionality assessment; Other: Performance assessment; Other: ROM assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance assessment-Postural Stability Test
Postural Stability will be measured with the Biodex-BioSway 950-462 static balance device in single foot stance and double foot stance.
Measured: 1 year postoperatively
Static balance assessment-Stability Limit Test
Stability Limit will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.
Measured: 1 year postoperatively
Static balance assessment-Modified Sensori Organization Test
Modified Sensori Organization will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.
Measured: 1 year postoperatively
Dynamic balance assessment
Dynamic balances will be evaluated with the Y balance test.
Measured: 1 year postoperatively
Secondary outcomes (5)
Jumping performance assessment
Performance evaluation will be made with a single leg jump test.
Measured: 1 year postoperatively
Walking ability
Performance evaluation will be made with time up and go test.
Measured: 1 year postoperatively
Lower limb functionality assessment
Functionality will be evaluated with the Lower Extremity Functional Scale.
Measured: 1 year postoperatively
Foot and ankle functionality assessment
Functionality will be evaluated with the AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)
Measured: 1 year postoperatively
ROM assessment
Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start12 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Tear, Ankle, Lateral LigamentStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- seyit çıtaker, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788225
- Sponsor's protocol ID
- IAyas
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Balance and Function After Lateral Ankle Ligament Repair
- ClinicalTrials.gov ID
- NCT04788225
- Acronym / sponsor ID
- IAyas
- Keywords
- Lateral ankle ligaments repair, Postural Balance, Physical Functional Performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 9 Mar 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.
Approximately 85% of ankle injuries are lateral region injuries.Surgical repair of lateral ligaments is indicated if there is more than 20 degrees of varus or more than 15 mm translation, if conservative treatment is ineffective and degree of damage is high and chronic instability has developed.After the surgery in addition to pain and edema control, weight transfer is not performed on the ankle for 6 weeks.Therefore, this process may adversely affect the muscle strength and range of motion of the ankle, and lower extremity performance and muscular synergies of balance.Although pathological changes caused by ligament damage have been investigated very well in the literature, it is not clear how surgical repair affects these changes. In our study we aim to investigate post-surgical changes.
Primary aim of the study is to evaluate the balance parameters of individuals who have undergone anterior talofibular ligament and / or calcaneofibular ligament repair, and its secondary purpose is to evaluate lower extremity performance, ankle functionality, pain, range of motion and muscle strength and compare them with healthy individuals.
Our hypothesis is that the balance, lower extremity performance and functionality, pain, range of motion and muscle strength of patients who have undergone ankle lateral ligament repair are worse than healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ATFL repair by arthroscopic method | – | Other: Balance assessment, Other: Functionality assessment, Other: Performance assessment, Other: ROM assessmentPatients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Between the ages of 18-65 Volunteer to participate in the study Without any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder No history of fracture and surgical operation of the lower extremity |
| Control group | – | Other: Balance assessment, Other: Functionality assessment, Other: Performance assessment, Other: ROM assessmentBetween the ages of 18-65 Volunteer to participate in the study Healthy individuals with no disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone ATFL repair surgery at Gazi University Hospital The healthy control group will consist of patient relatives or volunteers to participate in the study.
Key inclusion criteria (1 listed)
- Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Volunteer to participate in the study
Key exclusion criteria (1 listed)
- Any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder, history of fracture and surgical operation of the lower extremity
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 |
|---|---|---|
| Balance assessmentAlso: Clinical assessmentStatic balances will be measured with the Biodex-BioSway 950-462 static balance device according to 3 different standard test procedures (Postural Stability Test, Stability Limit Test and Modified Sensori Organization Test) in single foot stance and double foot stance. Dynamic balances will be evaluated with the Y balance test. | Other | Control group, Patients with ATFL repair by arthroscopic method |
| Functionality assessmentAlso: Clinical assessmentFunctionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale) | Other | Control group, Patients with ATFL repair by arthroscopic method |
| Performance assessmentAlso: Clinical assessmentPerformance evaluation will be made with a single leg jump test and time up and go test. | Other | Control group, Patients with ATFL repair by arthroscopic method |
| ROM assessmentAlso: Clinical assessmentRange of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion. | Other | Control group, Patients with ATFL repair by arthroscopic method |
Primary outcome
Static balance assessment-Postural Stability Test
Time frame: 1 year postoperatively
Postural Stability will be measured with the Biodex-BioSway 950-462 static balance device in single foot stance and double foot stance.
Static balance assessment-Stability Limit Test
Time frame: 1 year postoperatively
Stability Limit will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.
Static balance assessment-Modified Sensori Organization Test
Time frame: 1 year postoperatively
Modified Sensori Organization will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.
Dynamic balance assessment
Time frame: 1 year postoperatively
Dynamic balances will be evaluated with the Y balance test.
5 secondary outcomes
Jumping performance assessment
Time frame: 1 year postoperatively
Walking ability
Time frame: 1 year postoperatively
Lower limb functionality assessment
Time frame: 1 year postoperatively
Foot and ankle functionality assessment
Time frame: 1 year postoperatively
ROM assessment
Time frame: 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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.
seyit çıtaker study director
Gazi 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 Complete Tear, Ankle, Lateral Ligament and Postural Balance, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact inci ayas (03122162621, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance assessment-Postural Stability Test (time frame: 1 year postoperatively). The study lists 4 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 9 Mar 2021.